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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 submitted an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
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
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 belowSelect...
I have provided a sample of my tumor that has not been treated with radiation.
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My small cell lung cancer worsened after treatment with a PD-1/PD-L1 inhibitor.
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My cancer can be measured by scans.
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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 is at stage IV.
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I have had one treatment for small cell lung cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
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 moreSecondary 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)
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
4,582,203 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,894 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,784 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have provided a sample of my tumor that has not been treated with radiation.You are expected to live for more than 3 months.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I have not had a serious wound, ulcer, or bone fracture that hasn't healed in the last 28 days.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years, except for basic hormone replacements.My small cell lung cancer worsened after initial chemotherapy and immunotherapy.I have not had any major bleeding or blood clot events in the last 3 months.My scans show my tumor is affecting major blood vessels or has hollow areas.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.I am currently being treated for an infection.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have brain metastases but am stable and either treated or untreated but asymptomatic.I have another cancer that is getting worse or was treated in the last 3 years.I was taken off a PD-1/L1 inhibitor due to side effects.I've had lung radiation of more than 30 Gray in the last 6 months.I have fluid buildup in my abdomen, chest, or around my heart.My small cell lung cancer worsened after treatment with a PD-1/PD-L1 inhibitor.My cancer can be measured by scans.I have or had lung inflammation that needed steroids.I had a gastrointestinal perforation less than 6 months ago.I have been diagnosed with HIV.I have received an organ or tissue transplant from another person.My small cell lung cancer diagnosis is confirmed and I need second-line therapy.I have a history of or currently have a neurological disorder related to cancer.I am not pregnant, breastfeeding, and if able to bear children, I am using birth control or abstaining from sex.I haven't had serious heart problems or major blood clot events in the last year.I had radiotherapy less than 2 weeks before starting the study treatment.I have a condition that affects how my body absorbs medication taken by mouth.I have a severe fistula.My small cell lung cancer is at stage IV.I have not had a live vaccine in the last 30 days.I have a history of inflammatory bowel disease.I have not had major surgery in the last 3 weeks.I have coughed up bright red blood recently.You currently have active hepatitis B or C.You've had a very bad allergic reaction to the study drug or any of its ingredients.I am Hepatitis B positive but have been on HBV antiviral therapy for over 4 weeks with an undetectable viral load.I will not breastfeed during the treatment and for 4 months after, or 1 week after taking lenvatinib, whichever is later.I am fully active or restricted in physically strenuous activity but can do light work.I had Hepatitis C but my viral load is now undetectable.I have had one treatment for small cell lung cancer.I have been treated with specific immune or targeted cancer therapies before.My blood pressure is ≤150/90 mm Hg and stable for the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Coformulation Pembrolizumab/Quavonlimab
- Group 2: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
- Group 3: Coformulation Pembrolizumab/Quavonlimab + MK-4830
- Group 4: Coformulation Favezelimab/Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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
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