coformulation favezelimab/pembrolizumab for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small Cell Lung Cancercoformulation favezelimab/pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: Up to approximately 60 months

Day 21
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Month 60
Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience at Least One Adverse Event (AE)
Objective Response Rate (ORR) 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)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Coformulation Pembrolizumab/Quavonlimab + MK-4830
1 of 4
Coformulation Pembrolizumab/Quavonlimab
1 of 4
Coformulation Favezelimab/Pembrolizumab
1 of 4
Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
1 of 4

Experimental Treatment

80 Total Participants · 4 Treatment Groups

Primary Treatment: coformulation favezelimab/pembrolizumab · No Placebo Group · Phase 1 & 2

Coformulation Pembrolizumab/Quavonlimab + MK-4830Experimental Group · 2 Interventions: coformulation pembrolizumab/quavonlimab, MK-4830 · Intervention Types: Biological, Biological
Coformulation Pembrolizumab/Quavonlimab
Biological
Experimental Group · 1 Intervention: coformulation pembrolizumab/quavonlimab · Intervention Types: Biological
Coformulation Favezelimab/Pembrolizumab
Biological
Experimental Group · 1 Intervention: coformulation favezelimab/pembrolizumab · Intervention Types: Biological
Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Group · 2 Interventions: coformulation pembrolizumab/quavonlimab, lenvatinib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 60 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,679 Previous Clinical Trials
4,956,971 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,267 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,638 Previous Clinical Trials
7,941,897 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy.
You have progressed on or after treatment with an anti-PD-1/PD-L1 mAb administered as part of first-line platinum-based systemic therapy for ES-SCLC.
You have received 1 prior line of systemic therapy for small cell lung cancer (SCLC).
Male participants must be abstinent from heterosexual intercourse or agree to use contraception during treatment for at least 7 days after the last dose of lenvatinib.
You have measurable disease per RECIST 1.