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Monoclonal Antibodies
Quavonlimab + Pembrolizumab for Advanced 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
For Dose Confirmation Phase SCLC Arm (Arm D): Have histologically- or cytologically-confirmed metastatic (Stage III/IV) SCLC with progressive disease after ≥1 platinum-based chemotherapy regimen. Participants with platinum-sensitive disease are eligible. Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Have Eastern Cooperative Oncology Group (ECOG) Performance Scale status of 0 or 1. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective during the intervention period and for at least 120 days after the last dose of pembrolizumab or pembrolizumab/quavonlimab, whichever comes last. Female participants of childbearing potential must have negative urine or serum pregnancy test within 24 hours for urine and within 72 hours for serum prior to receiving the first dose of study treatment. Male participants with a female partner(s) of child-bearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication and refrain from donating sperm during this period. Must submit an evaluable baseline tumor sample for analysis (either a recent or archival tumor sample)
For Efficacy Expansion Phase Arms F and G: Have histologically/cytologically-confirmed unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8, not amenable to local therapy. Have at least 1 measurable lesion by CT or MRI per RECIST 1.1 by BICR. Cutaneous lesions and other superficial lesions are not considered measurable lesions for the purposes of this protocol, but may be considered as non-target lesions. Participants with unresectable Stage III or IV disease must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies (combinations with anti-cytotoxic T-lymphocyte associated protein 4 [CTLA-4] agents will not be allowed). Participants who receive anti-PD-1 therapy as adjuvant treatment following complete resection of Stage III or IV melanoma and have disease recurrence (unresectable loco-regional disease or distant metastases) while on active treatment or within 6 months of stopping anti-PD-1 are eligible. Have submitted pre-trial imaging and provided a baseline tumor sample. Proto-oncogene B-raf (BRAF) V600 mutation-positive melanoma participants should have received targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however, they are not required to progress on this treatment prior to enrollment. BRAF V600E mutation-positive melanoma participants who have NOT received a BRAF inhibitor (either as adjuvant therapy or in the metastatic disease setting) with lactate dehydrogenase (LDH) < local upper limit of normal (ULN), no clinically significant tumor-related symptoms, and absence of rapidly progressing metastatic melanoma. Approximately 10 participants each from Arms F and G will have 2 mandatory biopsies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~2.5 years
Awards & highlights
Study Summary
This trial will study how safe and effective quavonlimab is when combined with pembrolizumab to treat advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors. Participants must have measurable disease, be in good physical condition (ECOG status of 0 or 1), and not pregnant or breastfeeding. They should have tried all other treatments without success, agree to use contraception, and provide a tumor sample. Certain types of cancer patients are excluded, like those with untreated brain metastases or active infections.Check my eligibility
What is being tested?
The study tests escalating doses of Quavonlimab combined with Pembrolizumab on participants with advanced solid tumors to evaluate safety, tolerability, how the body processes the drugs (pharmacokinetics), and initial effectiveness against the tumors.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, skin reactions, risk of infection due to immune system suppression; organ inflammation; hormonal gland problems leading to changes in mood or behavior.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coformulation: Number of participants discontinuing study treatment due to an AE
Coformulation: Number of participants with ≥1 AE
Coformulation: Number of participants with ≥1 DLT
+6 moreSecondary outcome measures
AUC of quavonlimab
Area under the plasma concentration time curve (AUC) of pembrolizumab
Chinese Cohort: AUC of pembrolizumab
+15 moreTrial Design
12Treatment groups
Experimental Treatment
Group I: Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm FExperimental Treatment2 Interventions
On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 in combination with pembrolizumab at pembrolizumab dose level 2 (PDL2). Both quavonlimab and pembrolizumab will be administered according to Schedule 2 for up to 24 months on study.
Group II: Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm GExperimental Treatment1 Intervention
On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 according to Schedule 2 for up to 24 months on study. Participants who demonstrate radiographically confirmed progressive disease in Arm G will be eligible to receive combination therapy with pembrolizumab (crossover).
Group III: Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1Experimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Escalation Phase, advanced solid tumor participants receive a single monotherapy dose lead-in with quavonlimab at dose level 1 (DL1). On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL1 in combination with pembrolizumab (pembro) at pembrolizumab dose level 1 (PDL1) according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
Group IV: Escalation: DL 3 Quavonlimab + Pembro: Cohort 3Experimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL3. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL3 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
Group V: Escalation: DL 2 Quavonlimab + Pembro: Cohort 2Experimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL2. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
Group VI: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm DExperimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with SCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL2 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.
Group VII: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm CExperimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and at DL2 quavonlimab according to Schedule 2. Participants will be treated for up to 35 cycles total on study.
Group VIII: Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm EExperimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
Group IX: Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm BExperimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL1 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.
Group X: Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm AExperimental Treatment2 Interventions
On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1, both according to Schedule 1. Participants will be treated for up to 35 cycles total on study.
Group XI: Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm IExperimental Treatment1 Intervention
On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants with advanced/metastatic solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.
Group XII: Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm KExperimental Treatment1 Intervention
On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants in mainland China with advanced solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,474 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,223 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an advanced cancer (not lung cancer for certain groups) and cannot or will not receive standard treatments.I have an advanced cancer that has spread, and I can't or won't use treatments that could help.I have been treated with a drug targeting CTLA-4 before.I have stage IIIB/IV NSCLC and haven't had systemic treatment for it, or it's been 6 months since my last early-stage treatment.I am in China, have an advanced cancer, and cannot or have not benefited from known treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A
- Group 2: Escalation: DL 2 Quavonlimab + Pembro: Cohort 2
- Group 3: Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F
- Group 4: Escalation: DL 3 Quavonlimab + Pembro: Cohort 3
- Group 5: Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1
- Group 6: Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G
- Group 7: Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B
- Group 8: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C
- Group 9: Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm K
- Group 10: Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I
- Group 11: Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E
- Group 12: Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D
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.
What other scientific papers are there on Pembrolizumab/Quavonlimab?
"Pembrolizumab/Quavonlimab is being studied in 1000 active clinical trials, with 122 of them in Phase 3. There are many locations for these trials, including 36034 sites just for Pembrolizumab/Quavonlimab clinical trials. For example, Houston, Texas has several Pembrolizumab/Quavonlimab clinical trials taking place."
Answered by AI
What is the purpose of this clinical trial?
"The primary objective of this trial, which will be measured over a period of up to 4 years, is the number of participants with at least one adverse event. Additionally, this study will also measure secondary outcomes including the number of participants who develop pembrolizumab-related antibodies (ADAs) and the minimum concentration (Cmin) of quavonlimab in the blood."
Answered by AI
What are the two FDA-approved indications for Pembrolizumab/Quavonlimab?
"Pembrolizumab/Quavonlimab is the standard of care for treating malignant neoplasms. This medication can also be used to manage unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
How many subjects will this research project be testing?
"This particular trial is no longer searching for patients. The study was first posted on July 2nd, 2017 and updated November 9th, 2022. However, there are 2584 other trials actively recruiting participants with solid tumors and 1000 studies for Pembrolizumab/Quavonlimab that may be of interest."
Answered by AI
Are participants being recruited for this experiment at this time?
"Information available on clinicaltrials.gov suggests that this trial is not presently recruiting patients for participation. Although the study has completed recruitment, it was first posted on July 2nd, 2017 and updated as recently as November 9th, 2020. There are 3584 other trials currently enrolling participants at this time."
Answered by AI
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