CompletedPhase 2

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

United States378 participantsStarted 2017-10-16

Plain-language summary

To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Male or female participants age ≥ 18 years of age at the time of informed consent
✓. Ability to provide and understand written informed consent prior to any study procedures
✓. Histologically or cytologically confirmed metastatic UM
✓. Must meet the following criteria related to prior treatment:
✓. HLA A\*0201 positive by central assay
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening
✓. Participants have measurable disease or non-measurable disease according to RECIST v1.1
✓. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug

Exclusion criteria

✕. Out-of-range laboratory values
✕. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
✕. Clinically significant cardiac disease or impaired cardiac function,
✕. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1. Participants with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of PD for at least 4 weeks by magnetic resonance imaging (MRI) prior to the first dose of study drug
✕. Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
✕. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated
✕. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection
✕. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type

What they're measuring

Efficacy: Overall Survival

Timeframe: From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.

Trial details

NCT IDNCT03070392

SponsorImmunocore Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-13

Results submitted2021-08-17

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