Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
ModernaTX, Inc.
Study ID
NCT03313778
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mRNA-4157 — BIOLOGICAL
    IM injection
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion
  • SoC Treatment — BIOLOGICAL
    Intravenous infusion

Study Details

The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.

Key Dates

First listed
Oct 18, 2017
Start date
Aug 14, 2017
Status verified
Feb 2026
Primary completion
Nov 21, 2027
Completion
Nov 21, 2027

Study Design

Enrollment
161 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose Escalation and Dose Expansion
    Participants will receive mRNA-4157 via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles.
  • Experimental: Part B: Dose Escalation and Dose Expansion
    Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.
  • Experimental: Part A2: Dose Expansion
    Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle and a SoC treatment every 2 weeks (Q2W) on Day 1 of each 21-day cycle starting from Cycle 5 of mRNA-4157 for up to 12 cycles.
  • Experimental: Part C: Dose Expansion
    Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.
  • Experimental: Part D: Dose Expansion
    Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 18 cycles (approximately 1 year of treatment), whichever is sooner.
  • Experimental: Part E1: Dose Expansion
    Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab every 6 weeks (Q6W) via IV infusion, and SoC chemotherapy every 3 weeks (Q3W) for up to 4 cycles during the perioperative and adjuvant phases.
  • Experimental: Part E2: Dose Expansion
    Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q6W via IV infusion, and SoC chemotherapy Q3W for up to 4 cycles during the perioperative and adjuvant phases.
  • Experimental: Part E3: Dose Expansion
    Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q3W via IV infusion, and SoC chemotherapy Q2W or Q3W for up to 4 cycles during the perioperative and adjuvant phases.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Part A and A2: Baseline through 100 days after last mRNA-4157 dose; Parts B, C, D, E1, E2, and E3: Baseline through 90 days after last pembrolizumab dose ]

Locations (10)

FacilityCityStateZIPSite coordinators
Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
The George Washington Cancer CenterWashington D.C.District of Columbia20037-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Florida Cancer SpecialistsSarasotaFlorida34232-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-9416-
Massachusetts General HospitalBostonMassachusetts02114-
NYU Langone Medical CenterNew YorkNew York10016-
The Cleveland Clinic FoundationClevelandOhio44195-0001-
UPMC Hillman Cancer CenterPittsburghPennsylvania15219-
UT Southwest Medical CenterDallasTexas75390-

Find similar trials in Los Angeles, CA

By research site
Angeles Clinic and Research Institute· Los Angeles, CAThe George Washington Cancer Center· Washington D.C., DCOrlando Health Cancer Institute· Orlando, FLFlorida Cancer Specialists· Sarasota, FLH Lee Moffitt Cancer Center and Research Institute· Tampa, FLMassachusetts General Hospital· Boston, MA

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