Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies

Part of paid clinical trials in Aurora, Colorado.

Sponsor
ModernaTX, Inc.
Study ID
NCT03323398
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Ovarian Cancer
  • Relapsed/Refractory Solid Tumor Malignancies or Lymphoma

Eligibility Criteria

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

Interventions

  • mRNA-2416 — BIOLOGICAL
    mRNA encoding human OX40L
  • Durvalumab — BIOLOGICAL
    PD-L1 inhibitor

Study Details

This clinical study will assess the safety and tolerability of escalating doses of mRNA-2416 alone and in combination with administered fixed doses of durvalumab in participants with relapsed/refractory solid tumor malignancies or lymphoma, as well as the objective response rate (ORR) of mRNA-2416 alone or in combination with durvalumab in ovarian cancer based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The applicable dose of mRNA-2416 will be injected directly into the participant's tumor (intratumoral) and the applicable dose of durvalumab will be administered intravenously.

Key Dates

Start date
Aug 15, 2017
Status verified
Jun 2024
Primary completion
Aug 18, 2021
Completion
Aug 18, 2021

Study Design

Enrollment
79 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: mRNA-2416 Alone
    Participants will be administered mRNA-2416 through an intratumoral injection at the applicable dose on Days 1 and 15 for six 28-day cycles.
  • Experimental: Arm B: mRNA-2416 in Combination with Durvalumab
    Participants will be administered mRNA-2416 through an intratumoral injection at the applicable dose on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 in combination with durvalumab through an intravenous infusion at a fixed dose on Day 1 of Cycles 1 through 6. The duration for each cycle is 28 days.

Primary Outcome Measure

Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) [ Time Frame: Days 1-28 (Cycle 1) ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-
Smilow Cancer HospitalNew HavenConnecticut06520-
Northwestern Memorial HospitalIndianapolisIndiana46202-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Minnesota Medical CenterMinneapolisMinnesota55455-
University of Oklahoma Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahoma73104-
Women & Infants HospitalProvidenceRhode Island02905-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Aurora, CO

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Colorado Hospital· Aurora, COSmilow Cancer Hospital· New Haven, CTNorthwestern Memorial Hospital· Indianapolis, INDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Minnesota Medical Center· Minneapolis, MN

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