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.

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT02697591

Recruitment Status:

Completed

Sponsor:

Incyte Biosciences International Sàrl

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
Yale University
New Haven Connecticut, 06511, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering at Monmouth
Middletown New Jersey, 07748, United States
MSK Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT02697591

Recruitment Status:

Completed

Sponsor:


Incyte Biosciences International Sàrl

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider