TerminatedPhase 1/2

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

Stopped: The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)

United States409 participantsStarted 2015-11-09

Plain-language summary

This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological or cytological diagnosis of advanced/metastatic solid tumor. Measurable disease by RECIST 1.1 with at least 1 measurable lesion that has not been previously irradiated. Availability of tumor specimen taken within 1 year prior to study entry, with no intervening systemic anti-cancer therapy. No prior PD-1/PDL-1 therapy allowed. Combination A: Phase 1b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, SCCHN, TNBC in any line of therapy, SCLC, 1st line NSCLC. 1st line NSCLC must demonstrate to express PD-L1. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination B: Phase 1b, patients with advanced solid tumors (NSCLC, SCCHN, melanoma) that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, or SCCHN. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination C: Ovarian cancer, SCCHN, NSCLC, gastric cancer, platinum resistant ovarian cancer. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. TGCT/PVNS that is either inoperable or requires extensive resection. Prior treatment with agents targeting CSF-1/CSF-1R not allowed. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangeme…

What they're measuring

Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination B

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination C

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination D

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F

Timeframe: Baseline up to first Cycle (up to 4 weeks)

Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A

Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)

Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B

Trial details

NCT IDNCT02554812

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-23

Results submitted2024-03-20

View on ClinicalTrials.gov More Advanced Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination B

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination C

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination D

Timeframe: Baseline up to Cycle 2 (up to 8 weeks)

Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F

Timeframe: Baseline up to first Cycle (up to 4 weeks)

Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A

Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)

Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B