TerminatedPhase 1/2

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Stopped: The study was terminated due to emergent data from another study and unrelated to safety.

United States10 participantsStarted 2017-11-21

Plain-language summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.

Who can participate

Age range

18 Years

Sex

ALL

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: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Phase 1: Subjects with advanced or metastatic solid tumors. * Phase 1: Subjects who have disease progression after treatment with available therapies. * Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma. * Presence of measurable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters not within the Protocol-defined range * Prior treatment with any tumor necrosis factor super family agonist. * 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. * Active autoimmune disease. * Known active central nervous system metastases and/or carcinomatous meningitis. * Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. * Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

Timeframe: Screening through 60 days after end of treatment, up to approximately 18 months

Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST

Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1

Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

Trial details

NCT IDNCT03277352

SponsorIncyte Biosciences International Sàrl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-01

Results submitted2021-07-01

View on ClinicalTrials.gov More Advanced Malignancies trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

Timeframe: Screening through 60 days after end of treatment, up to approximately 18 months

Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST

Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1

Timeframe: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months