Solid TumorPhase 2NCT06036836
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
A Phase 2 study testing favezelimab/pembrolizumab, pembrolizumab and lenvatinib in people with Solid Tumor and Cutaneous Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 44 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate pathologic complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) [Cohort A] and to evaluate lenvatinib in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Cutaneous Squamous Cell Carcinoma, Endometrial Cancer
- What is being tested?
- favezelimab/pembrolizumab, pembrolizumab and lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 44 sitesin 10 countries
- Study dates
- 29 Sep 2023to 12 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort A only
- Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
- Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
- Is systemic treatment naïve
- Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
- Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent
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- Cohort B only
- Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
- Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
- Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
- Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
- Has adequately controlled blood pressure without antihypertensive medication
- All Cohorts
- Agrees to follow contraception guidelines if a participant of childbearing potential
- Has a life expectancy >3 years per investigator assessment
- Has adequate organ function
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
- If positive for hepatitis C, has undetectable viral load at screening
- If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy
Who cannot join
- All Cohorts
- Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
- History of allogeneic tissue/solid organ transplant
- Cohort A only
- Received prior radiotherapy to the index lesion (in-field lesion)
- Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible
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- Cohort B
- Has had major surgery within 3 weeks prior to first dose of study interventions
- Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
- Has urine protein ≥1 g/24 hours
- Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
- Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Trial locations and contacts
44 sites in 10 countries.
44 sites in 10 countries
United States8 sites
St. Luke's University Health Network ( Site 0636)
Bethlehem, Pennsylvania, 18015
Dana-Farber Cancer Institute ( Site 0642)
Boston, Massachusetts, 02215
Cleveland Clinic Main ( Site 0639)
Cleveland, Ohio, 44195
UT Southwestern Medical Center-CRO-Simmons Comprehensive Cancer Center ( Site 0645)
Dallas, Texas, 75390-9179
Duke Cancer Institute ( Site 0641)
Durham, North Carolina, 27710
Rutgers Cancer Institute of New Jersey ( Site 0635)
New Brunswick, New Jersey, 08903
Yale-New Haven Hospital-Yale Cancer Center ( Site 0643)
New Haven, Connecticut, 06510
UPMC Hillman Cancer Center ( Site 0644)
Pittsburgh, Pennsylvania, 15232
Australia6 sites
Royal Brisbane and Women's Hospital ( Site 0002)
Brisbane, Queensland, 4029
St Vincent's Hospital-The Kinghorn Cancer Centre ( Site 0005)
Darlinghurst, New South Wales, 2010
The Alfred Hospital ( Site 0004)
Melbourne, Victoria, 3004
Fiona Stanley Hospital ( Site 0006)
Murdock, Western Australia, 6150
Royal North Shore Hospital ( Site 0008)
St Leonards, New South Wales, 2065
Blacktown Hospital ( Site 0003)
Sydney, New South Wales, 2148
Canada6 sites
Centre Hospitalier de l'Université de Montréal ( Site 0602)
Montreal, Quebec, H2X 3E4
Jewish General Hospital ( Site 0605)
Montreal, Quebec, H3T 1E2
McGill University Health Centre ( Site 0604)
Montreal, Quebec, H4A 3J1
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, G1J 1Z4
Sunnybrook Research Institute ( Site 0607)
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre ( Site 0606)
Toronto, Ontario, M5G 2M9
Turkey (Türkiye)6 sites
Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 0424)
Ankara, 06010
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0421)
Ankara, 06230
Liv Hospital Ankara-Oncology ( Site 0426)
Ankara, 06680
Ankara Bilkent Şehir Hastanesi ( Site 0427)
Ankara, 06800
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0423)
Istanbul, 34722
Medipol Mega Universite Hastanesi-oncology ( Site 0425)
Stanbul, Istanbul, 34214
France4 sites
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 0154)
Brest, Finistere, 29200
CENTRE LEON BERARD ( Site 0151)
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0155)
Paris, 75014
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0153)
Strasbourg, Alsace, 67200
Germany3 sites
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0183)
Dresden, Saxony, 01307
Universitaetsklinikum Essen ( Site 0185)
Essen, North Rhine-Westphalia, 45147
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0182)
Essen, North Rhine-Westphalia, 45147
Malaysia3 sites
Hospital Sultan Ismail-Pusat Rawatan Radioterapi Dan Onkologi ( Site 0063)
Johor Bahru, Johor, 81100
Sarawak General Hospital-Radiotherapy Unit ( Site 0062)
Kuching, Sarawak, 93586
University Malaya Medical Centre ( Site 0061)
Lembah Pantai, Kuala Lumpur, 59100
Netherlands3 sites
University Medical Center Groningen ( Site 0273)
Groningen, 9713GZ
Radboudumc ( Site 0274)
Nijmegen, Gelderland, 6525 GA
Erasmus Medisch Centrum ( Site 0272)
Rotterdam, South Holland, 3015 GD
Taiwan3 sites
Taichung Veterans General Hospital-GYNECOLOGY ( Site 0033)
Taichung, 407
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0032)
Tainan, 704
National Taiwan University Hospital ( Site 0031)
Taipei, 10002
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori-SC Oncologia Medica 3 - Tumori Testa-collo ( Site 025
Milan, Lombardy, 20133
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
Naples, 80131
About this study
Official title: A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)
The purpose of this study is to evaluate pathologic complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) [Cohort A] and to evaluate lenvatinib in combination with coformulated favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in participants proficient in mismatch repair (pMMR) endometrial cancer (EC) [Cohort B].
- Being tested
- favezelimab/pembrolizumab, pembrolizumab, lenvatinib
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death-2 (PD2, PD-2), Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2), Lymphocyte-Activation Gene 3 (LAG-3)
- Medical subject headings
- Endometrial Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
favezelimab/pembrolizumabBiological
Also called MK-4280A
IV infusion
pembrolizumabBiological
Also called MK-3475, Keytruda®
IV infusion
lenvatinibDrug
Oral administration of capsule
| Study group | Role | What they receive |
|---|---|---|
| Favezelimab/Pembrolizumab | Experimental | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles. Receives: Biological: favezelimab/pembrolizumab |
| Pembrolizumab | Experimental | Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles. Receives: Biological: pembrolizumab |
| Favezelimab/Pembrolizumab + Lenvatinib (Cohort B) | Experimental | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met. Receives: Biological: favezelimab/pembrolizumab; Drug: lenvatinib |
| Pembrolizumab + Lenvatinib (Cohort B) | Experimental | Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met. Receives: Biological: pembrolizumab; Drug: lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate - Cohort A
Clinical benefit rate is defined as the percentage of participants who have clinical benefit. Clinical benefit is defined as major pathologic response (mPR) or pCR in participants who undergo surgery, or clinical complete response (cCR) [defined as residual tumor not visible on clinical exam nor on imaging and a negative biopsy, if biopsy is available, in participants who decline surgery.
Measured: Up to approximately 22 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B
The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to approximately 21 months
Secondary outcomes (7)
Pathologic Complete Response (pCR) - Cohort A
pCR is defined as complete absence of viable tumor in the surgical resection sample as assessed by local review of the pathology results. Number of Cohort A participants with pCR will be reported.
Measured: Up to approximately 22 months
Major Pathologic Response (mPR) - Cohort A
mPR is defined as the presence of ≤10% of viable tumors in the surgical resection sample as assessed by local review of the pathology results. The number of Cohort A participants with mPR will be reported.
Measured: Up to approximately 22 months
ORR per RECIST 1.1 as assessed by Investigator - Cohort A
The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to approximately 22 months
Number of participants with an adverse event (AE) - Cohorts A and B
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.
Measured: Up to approximately 41 months
Number of participants discontinuing from study therapy due to AE - Cohorts A and B
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 41 months
Number of participants experiencing perioperative complications - Cohort A
The number of participants who experience perioperative complications will be assessed.
Measured: Up to approximately 18 weeks
Number of participants with an AE that precludes surgery - Cohort A
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of Cohort A participants with an AE that precludes surgery will be reported.
Measured: Up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start29 Sep 2023
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036836
- Sponsor's protocol ID
- 4280A-010
- Other IDs
- MK-4280A-010, 2023-505022-34-00, U1111-1290-7288, 2023
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)
- ClinicalTrials.gov ID
- NCT06036836
- Acronym / sponsor ID
- 4280A-010
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death-2 (PD2, PD-2), Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2), Lymphocyte-Activation Gene 3 (LAG-3)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate pathologic complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) [Cohort A] and to evaluate lenvatinib in combination with coformulated favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in participants proficient in mismatch repair (pMMR) endometrial cancer (EC) [Cohort B].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Favezelimab/Pembrolizumab | Experimental | Biological: favezelimab/pembrolizumabParticipants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles. |
| Pembrolizumab | Experimental | Biological: pembrolizumabParticipants will receive 200 mg pembrolizumab via an IV infusion Q3W for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles. |
| Favezelimab/Pembrolizumab + Lenvatinib (Cohort B) | Experimental | Biological: favezelimab/pembrolizumab, Drug: lenvatinibParticipants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met. |
| Pembrolizumab + Lenvatinib (Cohort B) | Experimental | Biological: pembrolizumab, Drug: lenvatinibParticipants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Cohort A only
- Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
- Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
- Is systemic treatment naïve
- Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
Key exclusion criteria (13 listed)
- All Cohorts
- Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
- History of allogeneic tissue/solid organ transplant
- Cohort A only
- Received prior radiotherapy to the index lesion (in-field lesion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| favezelimab/pembrolizumabAlso: MK-4280AIV infusion | Biological | Favezelimab/Pembrolizumab, Favezelimab/Pembrolizumab + Lenvatinib (Cohort B) |
| pembrolizumabAlso: MK-3475, Keytruda®IV infusion | Biological | Pembrolizumab, Pembrolizumab + Lenvatinib (Cohort B) |
| lenvatinibOral administration of capsule | Drug | Favezelimab/Pembrolizumab + Lenvatinib (Cohort B), Pembrolizumab + Lenvatinib (Cohort B) |
Primary outcome
Clinical Benefit Rate - Cohort A
Time frame: Up to approximately 22 months
Clinical benefit rate is defined as the percentage of participants who have clinical benefit. Clinical benefit is defined as major pathologic response (mPR) or pCR in participants who undergo surgery, or clinical complete response (cCR) [defined as residual tumor not visible on clinical exam nor on imaging and a negative biopsy, if biopsy is available, in participants who decline surgery.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B
Time frame: Up to approximately 21 months
The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
7 secondary outcomes
Pathologic Complete Response (pCR) - Cohort A
Time frame: Up to approximately 22 months
Major Pathologic Response (mPR) - Cohort A
Time frame: Up to approximately 22 months
ORR per RECIST 1.1 as assessed by Investigator - Cohort A
Time frame: Up to approximately 22 months
Number of participants with an adverse event (AE) - Cohorts A and B
Time frame: Up to approximately 41 months
Number of participants discontinuing from study therapy due to AE - Cohorts A and B
Time frame: Up to approximately 41 months
Number of participants experiencing perioperative complications - Cohort A
Time frame: Up to approximately 18 weeks
Number of participants with an AE that precludes surgery - Cohort A
Time frame: Up to approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
44 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing favezelimab/pembrolizumab, pembrolizumab and lenvatinib in people with Solid Tumor and Cutaneous Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 44 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Australia, Canada, Turkey (Türkiye), France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate - Cohort A (time frame: Up to approximately 22 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.