WithdrawnPhase 1/2

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

United States0Started 2015-11

Plain-language summary

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.

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.

Inclusion criteria

✓. Age ≥ 18 years
✓. Written informed consent must be obtained from all patients prior to any study procedures
✓. Patients with advanced non-uveal melanoma defined as unresectable stage III or metastatic stage IV disease. Patients with acral or mucosal melanoma are acceptable. Patients with melanoma of unknown primary are acceptable for Phase 1b escalation cohorts (Arms 1 to 5) but are excluded in Phase 2. NOTE: Patients with the diagnosis of UM are excluded from all cohorts
✓. Phase 1b (Arm 4 and Arm 5) and Phase 2: Patients with disease progression following initiation of treatment with an approved PD-(L)1 inhibitor. Patients with BRAF mutations should be refractory to approved BRAF-inhibitor if clinically feasible. CTLA 4 inhibition therapy is acceptable as a prior line of therapy or in combination with anti-PD-(L)1 therapy. For Phase 2, no prior chemotherapy in the advanced setting is permitted
✓. Phase 1b Arms 1-3: no restriction on prior therapy
✓. HLA-A\*02:01 positive by central assay or by an 510K approved assay run in CLIA-certified laboratory
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
✓. Life expectancy of at least 3 months

Exclusion criteria

What they're measuring

Phase 2: Objective Response Rate (ORR)

Timeframe: Up to ~2 years

Trial details

NCT IDNCT02535078

SponsorImmunocore Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-19

View on ClinicalTrials.gov More Malignant Melanoma trials