Melanoma Clinical Trial
A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
Summary
This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
Part 1: Participants with advanced or metastatic solid tumors.
Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion Criteria:
Laboratory and medical history parameters not within the protocol-defined range.
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
Receipt of a live vaccine within 30 days of planned start of study therapy.
Active autoimmune disease.
Prior treatment with any tumor necrosis factor super family agonist.
Known active central nervous system metastases and/or carcinomatous meningitis.
Evidence of active, non-infectious pneumonitis or history of interstitial lung disease.
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
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There are 7 Locations for this study
Los Angeles California, 90025, United States
New Haven Connecticut, 06511, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Middletown New Jersey, 07748, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Nashville Tennessee, 37232, United States
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