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Monoclonal Antibodies

Favezelimab/Pembrolizumab for Squamous Cell Carcinoma

Q: What is the overarching objective of this clinical exploration?

<p>Per the study sponsor Merck Sharp &#x26; Dohme LLC, this research is investigating Objective Response Rate (ORR) per RECIST 1.1 criteria as its primary objective over a course of up to 22 months - Cohort B. Additionally, there are secondary goals such as Clinical Benefit Rate - Cohort A denoting participants with clinical benefit; Event-Free Survival - Cohort A measuring time from randomization till first progression or death prior to surgical resection; and Major Pathological Response - Cohort A observing ≤10% viable tumor cells in the surgery sample based on central review.</p>

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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. 9

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 41 months

Awards & highlights

Study Summary

This trial evaluates two cancer treatments for cSCC and pMMR EC to see how effective they are.

Who is the study for?

This trial is for adults with certain solid tumors: cutaneous squamous cell carcinoma without distant metastasis, or endometrial cancer that's either stage IVB, recurrent, or metastatic and not suitable for curative surgery. Participants must have progressed after platinum-based chemotherapy and be systemic treatment naïve. They cannot join if they have mismatch repair-deficient tumors.Check my eligibility

What is being tested?

The study tests favezelimab coformulated with pembrolizumab (MK-4280A) versus pembrolizumab alone in patients with skin cancer; it also examines lenvatinib plus MK-4280A/pembrolizumab in endometrial cancer patients. The focus is on the complete response rate in skin cancer and objective response rate in endometrial cancer.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, changes to blood counts which can affect infection risk and organ function. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer is confirmed to be squamous cell carcinoma and can be surgically removed.

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My cancer is between Stage II and IV and has not spread far.

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My endometrial cancer is at an advanced stage and cannot be treated with surgery or radiation.

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My endometrial cancer is not mismatch repair deficient.

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I have not received any systemic treatments.

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My cancer progressed after one platinum-based treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 41 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 41 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 41 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B

Pathological Complete Response (pCR) - Cohort A

Secondary outcome measures

Clinical Benefit Rate - Cohort A

Duration of Response (DOR) - Cohort B

Event-Free Survival (EFS) - Cohort A

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Pembrolizumab + Lenvatinib (Cohort B)Experimental Treatment2 Interventions

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.

Group II: PembrolizumabExperimental Treatment1 Intervention

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.

Group III: Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)Experimental Treatment2 Interventions

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.

Group IV: Favezelimab/PembrolizumabExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5750

lenvatinib

2018

Completed Phase 2

~270

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,986 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,064,059 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research trial currently seeking participants?

"As indicated by clinicaltrials.gov, this research project is presently accepting applicants. This medical trial was first posted on September 29th 2023 and has since been updated in late November of the same year."

Answered by AI

What is the geographic coverage of this experimental endeavor?

"There are 8 trial sites offering this study, including the Fiona Stanley Hospital (Site 0006) in Murdock, Royal North Shore Hospital ( Site 0008) in St Leonards and Rutgers Cancer Institute of New jersey ( Site 0635) in New Brunswick. Additionally, there are 5 other places that participants can access this medication."

Answered by AI

Has the Federal Drug Administration certified Favezelimab/Pembrolizumab?

"With Phase 2 trial data suggesting a certain degree of safety, Favezelimab/Pembrolizumab was rated a 2 on the Power Team's scale. Unfortunately, there is not yet any clinical evidence confirming its efficacy."

Answered by AI

How many research participants are engaged in this investigation?

"This clinical trial necessitates 160 eligible candidates to participate, with enrolment sites including the Fiona Stanley Hospital in Murdock, New South Wales and Royal North Shore Hospital in St Leonards, New jersey."

Answered by AI

What is the overarching objective of this clinical exploration?

"Per the study sponsor Merck Sharp & Dohme LLC, this research is investigating Objective Response Rate (ORR) per RECIST 1.1 criteria as its primary objective over a course of up to 22 months - Cohort B. Additionally, there are secondary goals such as Clinical Benefit Rate - Cohort A denoting participants with clinical benefit; Event-Free Survival - Cohort A measuring time from randomization till first progression or death prior to surgical resection; and Major Pathological Response - Cohort A observing ≤10% viable tumor cells in the surgery sample based on central review."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)

2023. "Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036836.