Elicit: Interventional Trials in Metastatic Head and Neck SCC (CT, public)
Interventional Trials in Metastatic Head and Neck SCC (CT, public)
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July 29, 2025
phase 3 metastatic squamous cell carcinoma of head and neck that started after 2015 that are also interventional and industry sponsored
Twenty-one phase 3, interventional, industry-sponsored trials in metastatic head and neck squamous cell carcinoma have been initiated since 2015, with varying current status ranging from recruiting to terminated.
Abstract
Twenty-one phase 3, interventional, industry‐sponsored trials in metastatic head and neck squamous cell carcinoma initiated after 2015 have been registered. Fifteen trials evaluate anti–PD-1/PD-L1 agents as single agents or in combination, while 12 assess these agents paired with novel immunotherapies (for example, bispecific antibodies, vaccines, fusion proteins) or with tyrosine kinase inhibitors, chemotherapy, or anti–EGFR therapy.
Seventeen studies list overall survival, progression-free survival, and response rate as primary endpoints but have not reported results. No study has detailed quantitative safety outcomes such as grade 3–4 adverse events or treatment discontinuations. Enrollment is often limited by biomarker criteria (eg, PD-L1 Combined Positive Score thresholds or HPV16 positivity), although subgroup data are not available. Among the trials, nine are recruiting, one is active but not recruiting, two are active with published results, five have completed with available results, and three were terminated with results reported.
Methods
We analyzed 38 sources from an initial pool of 500, using 7 screening criteria. Each paper was reviewed for 5 key aspects that mattered most to the research question. More on methods
Papers identified with Elicit search
n = 500
Papers screened using: Population - Cancer Type, Population - Disease Stage, Study Design - Trial Phase, Study Design - Type, Study Sponsorship, Study Timeline, Population Exclusions
n = 500
Papers screened out
n = 462
Papers included for extraction
n = 38
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Paper search
Using your research question “phase 3 metastatic squamous cell carcinoma of head and neck that started after 2015 that are also interventional and industry sponsored”, we searched across all trials from the ClinicalTrials.gov corpus. We retrieved the 500 trials most relevant to the query.
Screening
We screened in sources based on their abstracts that met these criteria:
- Population - Cancer Type: Does the study specifically focus on patients with squamous cell carcinoma of head and neck (HNSCC)?
- Population - Disease Stage: Does the study include patients with metastatic disease?
- Study Design - Trial Phase: Is this a Phase 3 clinical trial?
- Study Design - Type: Is this an interventional study?
- Study Sponsorship: Is the study sponsored (fully or partially) by industry?
- Study Timeline: Did the study start on or after January 1, 2015?
- Population Exclusions: Does the study focus exclusively on HNSCC patients (without including other cancer types)?
We considered all screening questions together and made a holistic judgement about whether to screen in each paper.
Data extraction
We asked a large language model to extract each data column below from each paper. We gave the model the extraction instructions shown below for each column.
- Study Type and Phase:
Extract the specific study type (e.g., interventional) and exact phase (e.g., Phase 3) as listed in the clinical trial registration or methods section. If multiple phases are mentioned (e.g., Phase 2/3), record both.
Verification steps:
- Check clinical trial registration
- Confirm phase in methods section of full text
- If discrepancies exist, prioritize the most recent or most detailed source
Acceptable responses include:
Interventional, Phase 3
Interventional, Phase 2/3
Sponsorship Details:
Identify the primary sponsor of the study. Look for:
- Industry sponsor name
- Funding source
- Sponsoring organization
Verification steps:
- Check acknowledgments section
- Review conflicts of interest statement
- Examine funding declaration
If multiple sponsors exist, list the primary industry sponsor. If no clear industry sponsor is found, note “Not specified” or “Non-industry sponsored”.
- Participant Eligibility Criteria:
Extract key inclusion and exclusion criteria specific to:
- Disease stage (metastatic squamous cell carcinoma)
- Age range
- Performance status
- Prior treatments
Specific focus areas:
- Confirm metastatic status
- Note any specific subtype restrictions
- Record minimum and maximum age
- List any critical exclusion criteria
If criteria are complex, summarize the most important points. Use direct quotes from eligibility criteria when possible.
- Geographical Locations:
List all countries where the study is being conducted.
Extraction method:
- Count total number of countries
- List each country exactly as it appears in the trial registration
- If multiple sites exist within a country, just list the country name
Example format:
United States
China
Multiple European countries
Primary Intervention:
Describe the primary intervention in detail:
- Specific drugs/treatments used
- Combination therapies
- Dosage (if specified)
- Administration method
Extraction guidelines:
- Use precise terminology from the study
- Include all components of the intervention
- Note any comparative or combination treatments
Example format: “Zanzalintinib (XL092) + Pembrolizumab” or “Cisplatin plus Raltitrexed concurrent with Radiotherapy”
Results
Characteristics of Included Studies
Study ID
Intervention Type
Primary Endpoints
Trial Status
Merck Sharp & Dohme LLC, 2025a
Pembrolizumab (neoadjuvant and adjuvant) + radiotherapy with or without cisplatin
Event-free survival
Active, not recruiting
AVEO Pharmaceuticals, Inc., 2025
Ficlatuzumab + cetuximab vs placebo + cetuximab
Efficacy (Overall Survival, Progression-Free Survival), safety
Recruiting
Merus N.V., 2025a
Petosemtamab + pembrolizumab vs pembrolizumab
Efficacy, safety
Recruiting
Merus N.V., 2025b
Petosemtamab vs investigator’s choice monotherapy
Efficacy, safety
Recruiting
GlaxoSmithKline and Merck Sharp & Dohme LLC, 2024a
GSK3359609 + pembrolizumab vs pembrolizumab
Efficacy (Overall Survival, Progression-Free Survival), safety
Terminated, results available
Inhibrx Biosciences, Inc., 2025
INBRX-106 + pembrolizumab vs pembrolizumab
Efficacy, safety
Recruiting
Akeso, 2024
AK112 + AK117 vs pembrolizumab
Efficacy, safety
Recruiting
Incyte Corporation and Merck Sharp & Dohme LLC, 2025
Pembrolizumab + epacadostat vs pembrolizumab vs EXTREME regimen (cetuximab, platinum, and 5-fluorouracil)
Efficacy, safety
Active, not recruiting, results available
Merck Sharp & Dohme LLC and Eisai Inc., 2025a
Pembrolizumab + lenvatinib vs pembrolizumab + placebo
Objective Response Rate, Progression-Free Survival, Overall Survival
Completed, results available
PDS Biotechnology Corp., 2025
PDS0101 + pembrolizumab vs pembrolizumab
Overall Survival, Objective Response Rate, Disease Control Rate, Duration of Response, Progression-Free Survival
Recruiting
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Summary of intervention types:
- Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/PD-L1) agents:Found in 15 studies, either alone or in combination.
- Anti-PD-1/PD-L1 agents with novel immunotherapies:12 studies tested combinations with bispecific antibodies, vaccines, fusion proteins, anti-Inducible T-cell COStimulator (ICOS), anti-NKG2A, interleukin-2 (IL-2) agonist, or indoleamine 2,3-dioxygenase (IDO) inhibitor.
- Anti-PD-1/PD-L1 agents with tyrosine kinase inhibitors:2 studies.
- Anti-PD-1/PD-L1 agents with or without chemotherapy:3 studies.
- Anti-Epidermal Growth Factor Receptor (EGFR) (cetuximab) in combination regimens:4 studies.
- Chemotherapy as comparator or Standard of Care/EXTREME regimen:4 studies.
- Cancer vaccines (PDS0101, BNT113) with anti-PD-1:2 studies.
- Novel immunotherapies (petosemtamab, SCT-I10A, AK112/AK117, INBRX-106, ficerafusp alfa) as monotherapy or in combination:6 studies.
Summary of trial status:
- 9 studies were recruiting.
- 1 study was active, not recruiting.
- 2 studies were active, not recruiting, with results available.
- 5 studies were completed, with results available.
- 3 studies were terminated, with results available.
- We didn’t find mention of the trial status for 1 study.
Summary of primary endpoints:
- 17 studies listed efficacy and safety as primary endpoints.
- 1 study listed event-free survival as the primary endpoint.
- 2 studies listed multiple efficacy endpoints (Overall Survival, Objective Response Rate, Disease Control Rate, Duration of Response, Progression-Free Survival).
- We didn’t find mention of unique primary endpoints in other studies.
Effects
Primary Outcomes
Study ID
Overall Survival
Progression-Free Survival
Response Rate
Merck Sharp & Dohme LLC, 2025a
No mention found (non-metastatic)
No mention found
No mention found
AVEO Pharmaceuticals, Inc., 2025
No mention found
No mention found
No mention found
Merus N.V., 2025a
No mention found
No mention found
No mention found
Merus N.V., 2025b
No mention found
No mention found
No mention found
GlaxoSmithKline and Merck Sharp & Dohme LLC, 2024a
No mention found (terminated)
No mention found
No mention found
Inhibrx Biosciences, Inc., 2025
No mention found
No mention found
No mention found
Akeso, 2024
No mention found
No mention found
No mention found
Incyte Corporation and Merck Sharp & Dohme LLC, 2025
No mention found
No mention found
No mention found
Merck Sharp & Dohme LLC and Eisai Inc., 2025a
No mention found
No mention found
No mention found
PDS Biotechnology Corp., 2025
No mention found
No mention found
No mention found
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Summary of findings:
- For Overall Survival:
- 17 studies had not yet reported results.
- 3 studies were terminated and did not report results.
- 1 study did not report results because it was non-metastatic.
- For Progression-Free Survival:
- 17 studies had not yet reported results.
- 4 studies did not report results.
- For Response Rate:
- 17 studies had not yet reported results.
- 4 studies did not report results.
- We didn’t find mention of reported results for Overall Survival, Progression-Free Survival, or Response Rate in any of the studies in the table.
Safety and Tolerability
Study ID
Grade 3-4 Adverse Events
Treatment Discontinuation
Notable Safety Findings
Merck Sharp & Dohme LLC, 2025a
No mention found
No mention found
No mention found
AVEO Pharmaceuticals, Inc., 2025
No mention found
No mention found
No mention found
Merus N.V., 2025a
No mention found
No mention found
No mention found
Merus N.V., 2025b
No mention found
No mention found
No mention found
GlaxoSmithKline and Merck Sharp & Dohme LLC, 2024a
No mention found
No mention found
No mention found
Inhibrx Biosciences, Inc., 2025
No mention found
No mention found
No mention found
Akeso, 2024
No mention found
No mention found
No mention found
Incyte Corporation and Merck Sharp & Dohme LLC, 2025
No mention found
No mention found
No mention found
Merck Sharp & Dohme LLC and Eisai Inc., 2025a
No mention found
No mention found
No mention found
PDS Biotechnology Corp., 2025
No mention found
No mention found
No mention found
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Summary of findings:
- For 17 studies, we found “No mention found” for all three safety outcomes.
- For 4 studies, we found “No mention found” for all three safety outcomes.
- We didn’t find mention of any quantitative or descriptive data for Grade 3-4 adverse events, treatment discontinuation, or notable safety findings in any of the studies in this table.
Subgroup Analyses
Biomarker-Based Outcomes
- We didn’t find mention of biomarker-based efficacy or safety outcomes in the extracted data.
- Many studies restrict enrollment to biomarker-defined populations, such as Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 or ≥20, or Human Papillomavirus 16 (HPV16) positive, but results by biomarker subgroup are not available.
Regional Variations
- Most industry-sponsored studies are global, with sites in North America, Europe, Asia, and South America.
- A few studies are region-specific, such as Sinocelltech Ltd., 2020 in China and Merck KGaA, Darmstadt, Germany, 2022 in Germany.
- We didn’t find mention of regional efficacy or safety data.
Discussion
- We identified a large number of phase 3, interventional, industry-sponsored trials in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) initiated after 2015, with a strong focus on immunotherapy and combination regimens.
- The absence of mature efficacy and safety data from most studies limits the ability to draw conclusions regarding comparative effectiveness or tolerability.
- There is a trend toward studies that select patients based on specific biomarkers and test combinations of therapies, reflecting the evolving therapeutic landscape.
- Considerable heterogeneity exists across studies in terms of intervention types, endpoints, and inclusion criteria, which complicates synthesis of findings.
References
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Status
Gather sources
500 sources found
Details
Screen sources
38 sources included
Details
Extract data
190 data points extracted
Details
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NCT03765918: Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Lead Sponsor: Merck Sharp & Dohme LLC, Sponsor: None
NIH·
2025·
Citations unknown
ClinicalTrials
Study Type and Phase
Study Type: Interventional Phase: Phase 3
Sponsorship Details
Primary Sponsor: Merck Sharp & Dohme LLC
Study Director: Medical Director (STUDY_DIRECTOR) - Merck Sharp & Dohme LLC
This is an industry-sponsored clinical trial with Merck Sharp & Dohme LLC serving as both the lead sponsor and primary sponsor. Additional resources are available through Merck Clinical Trial Information.
Participant Eligibility Criteria
Disease Stage and Metastatic Status: This study specifically excludes metastatic disease. Participants must have non-metastatic, squamous cell carcinoma that is Stage III/IVA, resectable, locoregionally advanced. The study explicitly excludes patients with distant metastases and requires no distant metastases (M0).
Age Range: - Minimum age: 18 Years - No maximum age specified
Performance Status: - ECOG performance status of 0 or 1
Prior Treatments: The study requires treatment naïve participants with the following treatment exclusions: - No prior therapy with PD-1, PD-L1, or PD-L2 agents - No prior radiotherapy treatment or systemic anti-cancer therapy for the head and neck cancer under study
Disease Subtype Restrictions: - Limited to specific anatomical sites: oropharynx, larynx, hypopharynx, or oral cavity - Excludes cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer - For oropharyngeal tumors: HPV-positive Stage III requires T4, N0-2; HPV-negative allows Stage III or IVA
Critical Exclusion Criteria: - Stage T4B and/or N3 disease and/or distant metastases - Additional malignancy that is progressing or has required active treatment within the past 3 years - Central nervous system metastases - Immunodeficiency or immunosuppressive therapy
Geographical Locations
Total number of countries: 24
- Argentina - Australia - Austria - Belgium - Brazil - Canada - Chile - Colombia - France - Germany - Hungary - Ireland - Israel - Japan - Korea, Republic of - Poland - Portugal - Russian Federation - Spain - Switzerland - Taiwan - Ukraine - United Kingdom - United States
Primary Intervention
The primary intervention is Pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy.
Specific Components:
Pembrolizumab: - 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Given both neoadjuvantly (before surgery) and adjuvantly (after surgery)
Radiotherapy (intensity modulated radiation therapy): - 60 Gray: Low risk participants administered 2 Gray in 30 fractions - 66 Gray: High risk participants administered 2 Gray in 33 fractions - 70 Gray: Participants with gross residual disease administered 2 Gray in 35 fractions
Cisplatin (when used): - 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle
The intervention represents a multimodal approach combining immunotherapy (pembrolizumab) delivered both before and after surgery, with post-surgical radiotherapy, and optional concurrent cisplatin chemotherapy depending on patient risk factors.
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) (NCT03765918)
Summary
- Status: ACTIVE_NOT_RECRUITING
- Study Type: INTERVENTIONAL
- Phase: PHASE3
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Primary Purpose: TREATMENT
- Masking: NONE
- Enrollment: 714 participants (ACTUAL)
- Start Date: 2018-12-17
- Primary Completion Date: 2024-07-25
- Completion Date: 2026-09-10
- First Posted: 2018-12-05
- Last Update Posted: 2025-02-07
- Sponsor: Merck Sharp & Dohme LLC
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Conditions & Interventions
Conditions (1)
- Head and Neck Neoplasms Keywords: Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Interventions (5)
| Type | Name | Description | Arms |
|---|---|---|---|
| BIOLOGICAL | Pembrolizumab 200 mg | 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Pembro Neoadjuvant+Pembro SOC Adjuvant |
| RADIATION | Radiotherapy 60 Gray | Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy. | No Neoadjuvant+SOC Adjuvant, Pembro Neoadjuvant+Pembro SOC Adjuvant |
| RADIATION | Radiotherapy 66 Gray | High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy. | No Neoadjuvant+SOC Adjuvant, Pembro Neoadjuvant+Pembro SOC Adjuvant |
| RADIATION | Radiotherapy 70 Gray | Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy. | No Neoadjuvant+SOC Adjuvant, Pembro Neoadjuvant+Pembro SOC Adjuvant |
| DRUG | Cisplatin 100 mg/m^2 | 100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle | No Neoadjuvant+SOC Adjuvant, Pembro Neoadjuvant+Pembro SOC Adjuvant |
Outcomes
Primary Outcomes (1)
| Measure | Time Frame | Description |
|---|---|---|
| Event-free Survival (EFS) | Up to ~80 months | EFS is the time from the date of randomization to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause. Radiographic disease progression duri… |
Secondary Outcomes (8)
| Measure | Time Frame | Description |
|---|---|---|
| Major Pathological Response (mPR) | Up to ~64 months | The percentage of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes. |
| Overall Survival (OS) | Up to ~92 months | OS is the time from randomization to death due to any cause. |
| Pathological Complete Response (pCR) | Up to ~64 months | Pathological complete response (pCR) is measured as the percentage of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumo… |
| Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL) | Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months) | Change from baseline in the combined score of global health status (GHS)/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 29 and 30. Participant responses to questions regarding overall heal… |
| Change From Baseline in Global Health Status/Physical Functioning Scales | Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months) | Change from baseline in the combined score of physical functioning scale using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 1 through 5. Participant responses to questions regarding their physical functioning will … |
| Change from Baseline in Swallowing, Speech, and Pain Symptoms | Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months) | Change from baseline in the combined score of swallowing, speech, and pain symptoms using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&N35) items 31-38, 46, and 53-54. Participant responses to questions regarding problems with swallowing… |
| Percentage of Participants Experiencing An Adverse Event (AEs) | From time of first dose of study treatment until the end of follow-up (up to ~92 months) | Percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy |
| Percentage of Participants Discontinuing Study Drug Due to AEs | From time of first dose of study treatment until the end of treatment (up to 12 months) | Percentage of participants discontinuing study drug due to an AE |
Eligibility
- Age: Minimum: 18 Years
- Sex: ALL
- Accepts Healthy Volunteers: No
Eligibility Criteria
Inclusion Criteria:
- Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
- Is eligible for primary surgery based on investigator decision and per local practice
- Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
- Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
- Female participant that is not pregnant or breastfeeding
- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST version 1.1
- Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
- Has results from testing of HPV status for oropharyngeal cancer defined as p16
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
Exclusion Criteria:
- Has Stage T4B and/or N3 LA HNSCC and/or distant metastases
- Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC)
- Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.
- Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor
- Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start
- Has received a live vaccine within 30 days prior to randomization
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy
- Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis
- Has Grade ≥2 audiometric hearing loss
- Has Grade ≥2 neuropathy
- Has Grade 3-4 bleeding due to the underlying malignancy
- Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start
- Has had previous allogeneic tissue/solid organ transplant
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C (defined as Hepatitis C virus [HCV] ribonucleic acid is detected).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
Locations (192)
Study Officials
- Medical Director (STUDY_DIRECTOR) - Merck Sharp & Dohme LLC
Countries: Argentina (11), Australia (2), Austria (4), Belgium (3), Brazil (9), Canada (5), Chile (1), Colombia (4), France (7), Germany (12), Hungary (4), Ireland (1), Israel (5), Japan (11), Korea, Republic of (5), Poland (5), Portugal (4), Russian Federation (3), Spain (6), Switzerland (3), Taiwan (4), Ukraine (9), United Kingdom (6), United States (68)
| Facility | City | State/Province | Country | Status |
|---|---|---|---|---|
| Moores Cancer Center ( Site 1885) | La Jolla | California | United States | — |
| University of Southern California Norris Comprehensive Cancer Center ( Site 1850) | Los Angeles | California | United States | — |
| Hoag Memoriall Hospital Presbyterian ( Site 2056) | Newport Beach | California | United States | — |
| UC Davis Health System ( Site 1864) | Sacramento | California | United States | — |
| St. Joseph Heritage Healthcare ( Site 1806) | Santa Rosa | California | United States | — |
| University of Colorado Cancer Center ( Site 1838) | Aurora | Colorado | United States | — |
| MedStar Washington Hospital Center ( Site 2062) | Washington | District of Columbia | United States | — |
| George Washington University Medical Faculty Associates ( Site 2035) | Washington | District of Columbia | United States | — |
| University of Florida ( Site 1832) | Gainesville | Florida | United States | — |
| University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008) | Miami | Florida | United States | — |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054) | Orlando | Florida | United States | — |
| Orlando Health Cancer Institute ( Site 2061) | Orlando | Florida | United States | — |
| Saint Alphonsus Regional Medical Center ( Site 2021) | Boise | Idaho | United States | — |
| Beacon Cancer Care ( Site 2052) | Post Falls | Idaho | United States | — |
| Rush University Medical Center ( Site 1823) | Chicago | Illinois | United States | — |
| NorthShore University HealthSystem ( Site 1812) | Evanston | Illinois | United States | — |
| Loyola University Medical Center [Maywood, IL] ( Site 1817) | Maywood | Illinois | United States | — |
| University of Kansas Cancer Center ( Site 2004) | Westwood | Kansas | United States | — |
| University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069) | Lexington | Kentucky | United States | — |
| Ochsner Cancer Institute ( Site 2045) | New Orleans | Louisiana | United States | — |
| University of Maryland ( Site 2031) | Baltimore | Maryland | United States | — |
| Dana Farber Cancer Center ( Site 1873) | Boston | Massachusetts | United States | — |
| University of Massachusetts Memorial Medical Center ( Site 1875) | Worcester | Massachusetts | United States | — |
| Karmanos Cancer Institute ( Site 1870) | Detroit | Michigan | United States | — |
| Henry Ford Health System ( Site 1803) | Detroit | Michigan | United States | — |
| Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016) | Edina | Minnesota | United States | — |
| University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058) | Columbia | Missouri | United States | — |
| Washington University School of Medicine ( Site 1800) | Saint Louis | Missouri | United States | — |
| Mercy Clinic Cancer and Hematology - Chub O’Reilly Cancer Center ( Site 1897) | Springfield | Missouri | United States | — |
| St. Vincent Healthcare Frontier Cancer Center ( Site 1818) | Billings | Montana | United States | — |
| Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036) | Basking Ridge | New Jersey | United States | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039) | Middletown | New Jersey | United States | — |
| MSKCC-Bergen ( Site 2037) | Montvale | New Jersey | United States | — |
| Rutgers Cancer Institute of New Jersey ( Site 2071) | New Brunswick | New Jersey | United States | — |
| Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053) | Newark | New Jersey | United States | — |
| The University of New Mexico Comprehensive Cancer Center ( Site 1882) | Albuquerque | New Mexico | United States | — |
| Montefiore Einstein Center ( Site 2028) | Bronx | New York | United States | — |
| Erie County Medical Center ( Site 2047) | Buffalo | New York | United States | — |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038) | Commack | New York | United States | — |
| Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041) | Harrison | New York | United States | — |
| Monter Cancer Center ( Site 2060) | Lake Success | New York | United States | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014) | New York | New York | United States | — |
| Memorial Sloan Kettering Cancer Center ( Site 1857) | New York | New York | United States | — |
| Weill Cornell Medical College ( Site 2050) | New York | New York | United States | — |
| Northwell Health Cancer Institute ( Site 2030) | New York | New York | United States | — |
| Stony Brook University ( Site 2063) | Stony Brook | New York | United States | — |
| Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040) | Uniondale | New York | United States | — |
| Levine Cancer Institute ( Site 2003) | Charlotte | North Carolina | United States | — |
| Wake Forest Compenhensive Cancer Center ( Site 2029) | Winston-Salem | North Carolina | United States | — |
| Sanford Health Roger Maris Cancer Center ( Site 2034) | Fargo | North Dakota | United States | — |
| University Hospitals ( Site 2032) | Cleveland | Ohio | United States | — |
| The Ohio State University ( Site 2012) | Columbus | Ohio | United States | — |
| Providence Portland Medical Center ( Site 1843) | Portland | Oregon | United States | — |
| Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022) | Portland | Oregon | United States | — |
| Oregon Health Science University ( Site 1871) | Portland | Oregon | United States | — |
| St. Luke’s University Health Network ( Site 1801) | Bethlehem | Pennsylvania | United States | — |
| Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059) | Philadelphia | Pennsylvania | United States | — |
| Allegheny General Hospital ( Site 1833) | Pittsburgh | Pennsylvania | United States | — |
| Sanford Cancer Center Oncology Clinic ( Site 1859) | Sioux Falls | South Dakota | United States | — |
| Avera Cancer Institute- Research ( Site 2070) | Sioux Falls | South Dakota | United States | — |
| Henry Joyce Cancer Clinic ( Site 1827) | Nashville | Tennessee | United States | — |
| UT Southwestern Medical Center ( Site 1841) | Dallas | Texas | United States | — |
| USA Clinical Trials ( Site 2068) | San Antonio | Texas | United States | — |
| University of Utah, Huntsman Cancer Institute ( Site 1855) | Salt Lake City | Utah | United States | — |
| University of Vermont Medical Center ( Site 2009) | Burlington | Vermont | United States | — |
| UVA Health System - Emily Couric Cancer Center ( Site 1826) | Charlottesville | Virginia | United States | — |
| Inova Schar Cancer Institute ( Site 2026) | Fairfax | Virginia | United States | — |
| Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865) | Seattle | Washington | United States | — |
| Hospital Universitario Austral ( Site 0009) | Pilar | Buenos Aires | Argentina | — |
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019) | Buenos Aires | Caba | Argentina | — |
| Hospital Britanico de Buenos Aires ( Site 0012) | Ciudad de Buenos Aires | Caba | Argentina | — |
| Fundacion Estudios Clinicos-Oncology ( Site 0017) | Rosario | Santa Fe | Argentina | — |
| Sanatorio Britanico ( Site 0013) | Rosario | Santa Fe | Argentina | — |
| Instituto de Oncologia de Rosario ( Site 0002) | Rosario | Santa Fe | Argentina | — |
| Hospital Provincial del Centenario ( Site 0008) | Rosario | Santa Fe | Argentina | — |
| IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016) | Buenos Aires | — | Argentina | — |
| Hospital Aleman Buenos Aires Argentina ( Site 0004) | Buenos Aires | — | Argentina | — |
| Instituto de Oncología Angel Roffo ( Site 0003) | Buenos Aires | — | Argentina | — |
| CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010) | San Juan | — | Argentina | — |
| The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051) | Westmead | New South Wales | Australia | — |
| Royal Brisbane and Women s Hospital ( Site 0050) | Herston | Queensland | Australia | — |
| Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901) | Linz | Oberosterreich | Austria | — |
| Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902) | Graz | Steiermark | Austria | — |
| Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900) | Salzburg | — | Austria | — |
| Medizinische Universität Wien ( Site 1903) | Wien | — | Austria | — |
| Hopital de Jolimont ( Site 0103) | Haine Saint Paul | Hainaut | Belgium | — |
| UZ Gent ( Site 0101) | Gent | Oost-Vlaanderen | Belgium | — |
| AZ Nikolaas ( Site 0104) | Sint-Niklaas | Oost-Vlaanderen | Belgium | — |
| Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155) | Salvador | Bahia | Brazil | — |
| Centro Regional Integrado de Oncologia ( Site 0160) | Fortaleza | Ceara | Brazil | — |
| Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177) | Ipatinga | Minas Gerais | Brazil | — |
| Liga Norte Riograndense Contra o Cancer ( Site 0171) | Natal | Rio Grande Do Norte | Brazil | — |
| Hospital Nossa Senhora da Conceicao ( Site 0165) | Porto Alegre | Rio Grande Do Sul | Brazil | — |
| Hospital de Base de Sao Jose de Rio Preto ( Site 0153) | Sao Jose do Rio Preto | Sao Paulo | Brazil | — |
| Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169) | Rio de Janeiro | — | Brazil | — |
| Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167) | Sao Paulo | — | Brazil | — |
| BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175) | Sao Paulo | — | Brazil | — |
| Cross Cancer Institute ( Site 0201) | Edmonton | Alberta | Canada | — |
| Sunnybrook Research Institute ( Site 0211) | Toronto | Ontario | Canada | — |
| Princess Margaret Cancer Centre ( Site 0202) | Toronto | Ontario | Canada | — |
| McGill University Health Centre ( Site 0210) | Montreal | Quebec | Canada | — |
| CIUSSS de l’Estrie-CHUS ( Site 0209) | Sherbrooke | Quebec | Canada | — |
| Fundacion Arturo Lopez Perez FALP ( Site 0251) | Santiago | Region M. De Santiago | Chile | — |
| Clinica de la Costa S.A.S. ( Site 0307) | Barranquilla | Atlantico | Colombia | — |
| Centro de Investigacion Clinica del Country ( Site 0304) | Bogota | Distrito Capital De Bogota | Colombia | — |
| Oncologos del Occidente S.A. ( Site 0310) | Pereira | Risaralda | Colombia | — |
| Centro Medico Imbanaco de Cali S.A ( Site 0300) | Cali | Valle Del Cauca | Colombia | — |
| Centre Antoine Lacassagne ( Site 0351) | Nice | Alpes-Maritimes | France | — |
| Hopital de la Timone ( Site 0356) | Marseille | Bouches-du-Rhone | France | — |
| Institut Claudius Regaud IUCT Oncopole ( Site 0355) | Toulouse | Haute-Garonne | France | — |
| Institut Gustave Roussy ( Site 0353) | Villejuif | Val-de-Marne | France | — |
| Institut Sainte Catherine ( Site 0352) | Avignon | Vaucluse | France | — |
| Hopital Europeen Georges Pompidou ( Site 0358) | Paris | — | France | — |
| Institut Curie ( Site 0350) | Paris | — | France | — |
| Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401) | Tuebingen | Baden-Wurttemberg | Germany | — |
| Universitaetsklinikum Ulm ( Site 0402) | Ulm | Baden-Wurttemberg | Germany | — |
| Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412) | Erlangen | Bayern | Germany | — |
| Klinikum rechts der Isar der Technischen Universitaet ( Site 0409) | Muenchen | Bayern | Germany | — |
| Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405) | München | Bayern | Germany | — |
| Universitaetsklinikum Frankfurt ( Site 0403) | Frankfurt | Hessen | Germany | — |
| Klinikum Kassel GmbH ( Site 0404) | Kassel | Hessen | Germany | — |
| Universitaetsklinikum Koeln ( Site 0413) | Köln | Nordrhein-Westfalen | Germany | — |
| Universitätsklinikum Schleswig-Holstein ( Site 0411) | Luebeck | Schleswig-Holstein | Germany | — |
| SRH Wald-Klinikum Gera GmbH ( Site 0406) | Gera | Thuringen | Germany | — |
| Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414) | Berlin | — | Germany | — |
| Universitaetsklinikum Hamburg Eppendorf ( Site 0407) | Hamburg | — | Germany | — |
| Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452) | Pecs | Baranya | Hungary | — |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450) | Szolnok | Jasz-Nagykun-Szolnok | Hungary | — |
| Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453) | Budapest | — | Hungary | — |
| Orszagos Onkologiai Intezet ( Site 0454) | Budapest | — | Hungary | — |
| St. James s Hospital ( Site 0500) | Dublin | — | Ireland | — |
| Rambam Health Care Campus-Oncology Division ( Site 0550) | Haifa | — | Israel | — |
| Hadassah Medical Center. Ein Kerem ( Site 0554) | Jerusalem | — | Israel | — |
| Rabin Medical Center ( Site 0552) | Petah Tikva | — | Israel | — |
| Chaim Sheba Medical Center. ( Site 0553) | Ramat Gan | — | Israel | — |
| Sourasky Medical Center ( Site 0551) | Tel Aviv | — | Israel | — |
| Aichi Cancer Center Hospital ( Site 0658) | Nagoya | Aichi | Japan | — |
| National Cancer Center Hospital East ( Site 0661) | Kashiwa | Chiba | Japan | — |
| Hyogo Cancer Center ( Site 0656) | Akashi | Hyogo | Japan | — |
| Kagawa University Hospital ( Site 0651) | Kita-gun | Kagawa | Japan | — |
| Yokohama City University Hospital ( Site 0657) | Yokohama | Kanagawa | Japan | — |
| Chiba Cancer Center ( Site 0652) | Chiba | — | Japan | — |
| National Hospital Organization Kyushu Cancer Center ( Site 0660) | Fukuoka | — | Japan | — |
| Hiroshima University Hospital ( Site 0655) | Hiroshima | — | Japan | — |
| National Cancer Center Hospital ( Site 0650) | Tokyo | — | Japan | — |
| Tokyo Medical and Dental University Hospital ( Site 0654) | Tokyo | — | Japan | — |
| Tokyo Medical University Hospital ( Site 0659) | Tokyo | — | Japan | — |
| Chonnam National University Hwasun Hospital ( Site 0705) | Hwasun Gun | Jeonranamdo | Korea, Republic of | — |
| National Cancer Center ( Site 0702) | Goyang-si | Kyonggi-do | Korea, Republic of | — |
| The Catholic University of Korea St. Vincent s Hospital ( Site 0704) | Gyeonggi-do | Kyonggi-do | Korea, Republic of | — |
| Seoul National University Bundang Hospital ( Site 0703) | Seongnam-si | Kyonggi-do | Korea, Republic of | — |
| Severance Hospital, Yonsei University Health System ( Site 0701) | Seoul | — | Korea, Republic of | — |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920) | Lodz | Lodzkie | Poland | — |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905) | Krakow | Malopolskie | Poland | — |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie | Poland | — |
| Szpitale Pomorskie Sp. z o.o. ( Site 0935) | Gdynia | Pomorskie | Poland | — |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901) | Gliwice | Slaskie | Poland | — |
| Hospital de Braga ( Site 0951) | Braga | — | Portugal | — |
| CHLN Hospital Santa Maria ( Site 0952) | Lisboa | — | Portugal | — |
| Hospital CUF Descobertas ( Site 0953) | Lisboa | — | Portugal | — |
| Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950) | Porto | — | Portugal | — |
| N.N. Blokhin NMRCO ( Site 1005) | Moscow | Moskva | Russian Federation | — |
| Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000) | Kazan | Tatarstan, Respublika | Russian Federation | — |
| Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001) | Yaroslavl | Yaroslavskaya Oblast | Russian Federation | — |
| Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204) | Badalona | Barcelona | Spain | — |
| ICO L Hospitalet ( Site 1208) | Hospitalet de Llobregat | Barcelona | Spain | — |
| Hospital Clinico Universitario de Santiago ( Site 1207) | Santiago de Compostela | La Coruna | Spain | — |
| Hospital Vall D Hebron ( Site 1200) | Barcelona | — | Spain | — |
| Hospital Universitario La Paz ( Site 1201) | Madrid | — | Spain | — |
| Hospital Universitario Virgen del Rocio ( Site 1206) | Sevilla | — | Spain | — |
| Universitaetsspital Zurich ( Site 1923) | Zuerich | Aargau | Switzerland | — |
| Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921) | Bellinzona | Ticino | Switzerland | — |
| Hopitaux Universitaires de Geneve HUG ( Site 1920) | Geneve | — | Switzerland | — |
| Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303) | Kaohsiung | — | Taiwan | — |
| Taichung Veterans General Hospital ( Site 1301) | Taichung | — | Taiwan | — |
| National Cheng Kung University Hospital ( Site 1302) | Tainan | — | Taiwan | — |
| National Taiwan University Hospital ( Site 1300) | Taipei | — | Taiwan | — |
| Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709) | Dnipropetrovsk | Dnipropetrovska Oblast | Ukraine | — |
| Clinical oncology dispensary of Dnipro ( Site 1706) | Dnipro | Dnipropetrovska Oblast | Ukraine | — |
| Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705) | Dnipro | Dnipropetrovska Oblast | Ukraine | — |
| Ukrainian Center of Tomotherapy ( Site 1708) | Kropyvnitskiy | Kirovohradska Oblast | Ukraine | — |
| PP PPC Acinus Medical and Diagnostic Centre ( Site 1704) | Kropyvnytskyi | Kirovohradska Oblast | Ukraine | — |
| Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703) | Kapitanivka Village | Kyivska Oblast | Ukraine | — |
| National Cancer Institute of the MoH of Ukraine ( Site 1702) | Kyiv | Kyivska Oblast | Ukraine | — |
| LISOD. Hospital ( Site 1707) | Pliuty | Kyiv | Ukraine | — |
| Kyiv City Clinical Oncology Centre ( Site 1701) | Kyiv | — | Ukraine | — |
| Addenbrooke’s Hospital ( Site 1610) | Cambridge | Cambridgeshire | United Kingdom | — |
| Castle Hill Hospital ( Site 1601) | Cottingham-Hull | Kingston Upon Hull | United Kingdom | — |
| Guy s & St Thomas NHS Foundation Trust ( Site 1604) | London | London, City Of | United Kingdom | — |
| Royal Marsden Hospital - Fulham Road London ( Site 1609) | London | London, City Of | United Kingdom | — |
| Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603) | London | London, City Of | United Kingdom | — |
| Weston Park Hospital ( Site 1607) | Sheffield | — | United Kingdom | — |
Oversight & Regulatory
Data Monitoring Committee: Yes
FDA Regulation
- FDA Regulated Drug: Yes
- FDA Regulated Device: No
IPD Sharing Statement
IPD Sharing: YES
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php