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Protocol # 17-330

Status

Recruiting

Description

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

Condition

  • Solid Tumors

Interventions

  • mRNA-4157
  • Pembrolizumab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Number of Participants with Adverse Events

Secondary Outcome:

  • Percent Change from Baseline of Biomarker Levels in Tumors at Day 50
  • Antigen-Specific T-cell Responses in Peripheral Blood
  • Part C: Overall Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
  • Part C: Duration of Response (DoR)
  • Part C: Progression Free Survival (PFS)
  • Part C: Overall Survival (OS)

Enrollment

143

Study Start Date

August 14, 2017

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

ModernaTX, Inc.

Source

ModernaTX, Inc.

Official title

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Subjects With Resected Solid Tumors and in Combination With Pembrolizumab in Subjects With Unresectable Solid Tumors

Clinicaltrials.gov Identifier

NCT03313778

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.