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PD-1/PD-L1 Inhibitor

Pembrolizumab Combinations for Small Cell Lung Cancer

Phase 1 & 2
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 histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy
Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered as part of first-line platinum-based systemic therapy for ES-SCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will study the safety and efficacy of pembrolizumab in combination with investigational agents in people with anti-PD-1/PD-L1 refractory ES-SCLC who need second-line treatment. The trial will have two parts: a safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D), and an efficacy evaluation.

Who is the study for?
This trial is for adults with Stage IV small cell lung cancer who need second-line therapy after not responding to first treatments including PD-1/PD-L1 inhibitors. They must have a life expectancy over 3 months, measurable disease, and be willing to use contraception. Exclusions include recent major surgery or radiation, active infections, other cancers within 3 years, severe allergies to study drugs, and certain heart or blood vessel problems.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with investigational agents (quavonlimab/lenvatinib/MK-4830/favezelimab) in two parts: initial safety assessment followed by efficacy evaluation for those with extensive-stage small cell lung cancer resistant to standard treatments. No hypothesis testing; focuses on determining safe dosages and observing effectiveness.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, changes in blood pressure or heart rhythm issues due to lenvatinib's cardiovascular risks. Specific side effects will depend on the combination of drugs each participant receives.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My small cell lung cancer diagnosis is confirmed and I need second-line therapy.
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My small cell lung cancer worsened after treatment with a PD-1/PD-L1 inhibitor.
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My small cell lung cancer is at stage IV.
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I have had one treatment for small cell lung cancer.
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I am a man and will not have unprotected sex or will use contraception during and for 7 days after my treatment, unless I'm receiving specific immunotherapies.
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I am not pregnant, breastfeeding, and if able to bear children, I am using birth control or abstaining from sex.
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I will not breastfeed during the treatment and for 4 months after, or 1 week after taking lenvatinib, whichever is later.
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My cancer can be measured by scans.
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I have provided a sample of my tumor that has not been treated with radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am Hepatitis B positive but have been on HBV antiviral therapy for over 4 weeks with an undetectable viral load.
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I had Hepatitis C but my viral load is now undetectable.
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My blood pressure is ≤150/90 mm Hg and stable for the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 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
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience at Least One Adverse Event (AE)
+1 more
Secondary outcome measures
Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Coformulation Pembrolizumab/Quavonlimab + MK-4830Experimental Treatment2 Interventions
Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS MK-4830 800 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. MK-4830 will be administered by IV infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation.
Group II: Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation.
Group III: Coformulation Pembrolizumab/QuavonlimabExperimental Treatment1 Intervention
Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation.
Group IV: Coformulation Favezelimab/PembrolizumabExperimental Treatment1 Intervention
Participants receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) administered by intravenous (IV) infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lenvatinib
2018
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,582 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,844 Previous Clinical Trials
5,045,834 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,754 Previous Clinical Trials
8,058,444 Total Patients Enrolled

Media Library

Favezelimab (PD-1/PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04938817 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib, Coformulation Pembrolizumab/Quavonlimab + MK-4830, Coformulation Favezelimab/Pembrolizumab, Coformulation Pembrolizumab/Quavonlimab
Small Cell Lung Cancer Clinical Trial 2023: Favezelimab Highlights & Side Effects. Trial Name: NCT04938817 — Phase 1 & 2
Favezelimab (PD-1/PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938817 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment still accessible to participants?

"Per the available records on clinicaltrials.gov, this study is presently recruiting participants; it was first published on August 19th 2021 and most recently updated November 23rd 2022."

Answered by AI

What is the estimated enrollment for this experiment?

"This trial necessitates 80 candidates that match the prerequisites for inclusion. Richmond's Virginia Cancer Institute (Site 0169) and Atlanta's Georgia Cancer Specialists ( Site 0156) are two potential locations for participation."

Answered by AI

In which areas is this clinical trial accessible?

"The Virginia Cancer Institute in Richmond, Georgia Cancer Specialists in Atlanta and Cleveland Clinic-Taussig Cancer Center in Ohio are three of the 16 sites participating this clinical trial."

Answered by AI

What medical conditions can be addressed with the coformulation of favezelimab and pembrolizumab?

"Coformulation favezelimab/pembrolizumab can be used to treat individuals with unresectable melanoma, microsatellite instability high status and a heightened risk of relapse."

Answered by AI

What data have been gathered from research involving coformulation favezelimab/pembrolizumab?

"Currently, the quantity of studies tracking the efficacy of coformulation favezelimab/pembrolizumab is 1,032. Of these trials, 134 are in Phase 3 and 37,065 locations have opened up to participate in research related to this treatment. The majority of these sites are located in Sacramento California."

Answered by AI
~41 spots leftby Nov 2026