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Monoclonal Antibodies

Favezelimab + Pembrolizumab/Chemotherapy/Lenvatinib for Cancer

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Demonstrates adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 years
Awards & highlights

Study Summary

This trial is testing favezelimab as a possible treatment for people with metastatic solid tumors. The study will look at different doses of the drug and how well it works when used alone or in combination with other drugs.

Who is the study for?
Adults with metastatic solid tumors and no available beneficial therapy can join. They must be fairly active (ECOG 0 or 1), have good organ function, measurable disease by specific criteria, and agree to contraception if of child-bearing potential. Excluded are those with recent other treatments, CNS metastases, certain infections like HIV or hepatitis, unmanaged fluid buildup, heart issues affecting daily life, live vaccines recently taken, unresolved side effects from past cancer therapies over 4 weeks ago.Check my eligibility
What is being tested?
The trial is testing Favezelimab alone and combined with Pembrolizumab and/or chemotherapy drugs Oxaliplatin, Leucovorin (Calcium Folinate), Fluorouracil [5-FU], Lenvatinib or Irinotecan in adults with advanced solid tumors. It's a two-part study: first to find the safest dose combination (Part A) then confirming that dose while checking how well it works on different tumor types (Part B).See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site; fatigue; nausea; liver enzyme changes suggesting inflammation; skin rash; immune system complications potentially affecting various organs such as lungs causing pneumonitis or intestines leading to colitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are functioning well.
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My partner and I agree to use birth control during and after my treatment.
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My cancer has spread and this was confirmed through testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Discontinue Study Drug Due to an AE
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Number of Participants Who Experience at Least One Adverse Event (AE)
Secondary outcome measures
ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of Favezelimab in Combination With Pembrolizumab and FOLFIRI for Participants With Advanced Solid Tumors in Cohort B
ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of Favezelimab in Combination With Pembrolizumab and Lenvatinib for Participants With Advanced Solid Tumors in Cohort G
ORR as Determined by RECIST 1.1 as Assessed by Investigator Review of Favezelimab in Combination With Pembrolizumab and mFOLFOX7 for Participants With Advanced Solid Tumors in Cohort B
+15 more

Trial Design

18Treatment groups
Experimental Treatment
Group I: Part B: Favezelimab/PembrolizumabExperimental Treatment1 Intervention
Participants receive favezelimab/pembrolizumab (favezelimab and pembrolizumab administered as a co-formulation) IV infusion on Day 1 of each 21-day cycle.
Group II: Part B: Favezelimab Monotherapy DoseExperimental Treatment1 Intervention
Participants receive favezelimab monotherapy dose IV infusion on Day 1 of each 21-day cycle.
Group III: Part B: Favezelimab Dose H+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose H IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group IV: Part B: Favezelimab Dose G+Pembro+mFOLFOX7Experimental Treatment5 Interventions
Participants receive favezelimab Dose G IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours every 2 weeks [Q2W]).
Group V: Part B: Favezelimab Dose G+Pembro+LenvatinibExperimental Treatment3 Interventions
Participants receive favezelimab Dose G IV infusion on Day 1 of each 21 day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib (20 mg) each day of 21-day cycle.
Group VI: Part B: Favezelimab Dose G+Pembro+FOLFIRIExperimental Treatment5 Interventions
Participants receive favezelimab Dose G IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours Q2W).
Group VII: Part B: Favezelimab Dose G+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose G IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group VIII: Part B: Favezelimab Dose F+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose F IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group IX: Part A: Favezelimab Dose E+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose E IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group X: Part A: Favezelimab Dose EExperimental Treatment1 Intervention
Participants receive favezelimab Dose E IV infusion on Day 1 of each 21-day cycle.
Group XI: Part A: Favezelimab Dose D+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose D IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group XII: Part A: Favezelimab Dose DExperimental Treatment1 Intervention
Participants receive favezelimab Dose D IV infusion on Day 1 of each 21-day cycle.
Group XIII: Part A: Favezelimab Dose C+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose C IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group XIV: Part A: Favezelimab Dose CExperimental Treatment1 Intervention
Participants receive favezelimab Dose C IV infusion on Day 1 of each 21-day cycle.
Group XV: Part A: Favezelimab Dose B+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose B IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group XVI: Part A: Favezelimab Dose BExperimental Treatment1 Intervention
Participants receive favezelimab Dose B IV infusion on Day 1 of each 21-day cycle.
Group XVII: Part A: Favezelimab Dose A+PembroExperimental Treatment2 Interventions
Participants receive favezelimab Dose A IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab IV infusion administered sequentially on Day 1 of each 21-day cycle.
Group XVIII: Part A: Favezelimab Dose AExperimental Treatment1 Intervention
Participants receive favezelimab Dose A intravenous (IV) infusion on Day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Oxaliplatin
2011
Completed Phase 4
~2560
Lenvatinib
2005
Completed Phase 4
~2690
Irinotecan
2017
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,335 Total Patients Enrolled
5 Trials studying Tumors
149 Patients Enrolled for Tumors
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,258 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,205 Total Patients Enrolled
2 Trials studying Tumors
34 Patients Enrolled for Tumors

Media Library

Favezelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02720068 — Phase 1

Frequently Asked Questions

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

In what number of health centers is this clinical trial taking place?

"Patients are being recruited at 8 different clinics, including Call for Information (Investigational Site 0001) in San Antonio and Call for Information (Investigational Site 0019) in Denver. Additionally, the trial is also enrolling participants from Rochester, Minnesota (Call for Info - Investigational Site 0020), as well as 6 other sites."

Answered by AI

Can you please provide a summary of prior research initiatives involving Favezelimab/Pembrolizumab?

"Currently, there are 1631 clinical trials investigating Favezelimab/Pembrolizumab and 322 of these studies have reached the third phase. Most of them take place in Guangzhou, Guangdong; however, a total 61802 research sites around the globe are carrying out tests for this treatment."

Answered by AI

Are there any limitations on the participant pool for this clinical research project?

"At present, the trial is not accepting new patients. This study was first posted on May 2nd 2016 and last updated August 31st 2022. However, if you are searching for other trials that accommodate cancer sufferers there are 2379 active studies; similarly 1631 clinical trials recruiting participants with Favezelimab/Pembrolizumab as a treatment have been identified."

Answered by AI

Are there any openings presently available to take part in this investigation?

"According to clinicaltrials.gov, this particular medical trial is not recruiting participants at the moment; however, it was initially posted on May 2nd 2016 and last updated on August 31st 2022. Fortunately, there are 4010 other trials that presently have open enrollment slots for patients."

Answered by AI

What potential risks are associated with Favezelimab/Pembrolizumab?

"Since this is only a Phase 1 trial, which reflects limited data on safety and efficacy, Favezelimab/Pembrolizumab received the lowest rating of 1."

Answered by AI

What health conditions are Favezelimab/Pembrolizumab usually employed to address?

"Favezelimab/Pembrolizumab is suitable for treating malignant tumors, pervasive melanomas, and cells with high microsatellite instability."

Answered by AI
~65 spots leftby Mar 2025