Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Immunocore Ltd
Study ID
NCT02535078
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study was a mixed phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent, and in combination with durvalumab and/or tremelimumab, in metastatic cutaneous melanoma. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and to evaluate the anti-tumor activity of tebentafusp (IMCgp100) in combination with durvalumab (MEDI4736, programmed death-ligand 1 \[PD-L1\] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent tebentafusp (IMCgp100) alone administered as an intravenous or subcutaneous. The study will enroll patients who have metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor in the metastatic setting. This study will also evaluate the safety, tolerability, and anti-tumor activity of tebentafusp (IMCgp100) monotherapy in patients with advanced non-uveal melanoma who progressed on prior PD-1 inhibitors approved for the treatment of advanced melanoma; patients with BRAF mutations must be refractory to approved BRAF-based therapy.

Key Dates

Start date
Nov 30, 2015
Status verified
Jul 2024
Primary completion
Jun 19, 2023
Completion
Sep 6, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Tebentafusp SC Monotherapy
    Tebentafusp (IMCgp100) (single agent) subcutaneous (SC) injection

Primary Outcome Measure

Phase 2: Objective Response Rate (ORR) [ Time Frame: Up to ~2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic and Research Institute· Los Angeles, CAMemorial Sloan Kettering Cancer Center· New York, NYThomas Jefferson University Hospital· Philadelphia, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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