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NCT02178722
NCT02178722
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with one of these cancer types (confirmed by a tissue or cell sample): non-small cell lung cancer, melanoma, bladder/urinary tract cancer, kidney cancer, triple negative breast cancer, uterine cancer, head and neck cancer (Phase 1), or additionally ovarian cancer, a type of bowel cancer with a specific genetic marker (MSI high), stomach cancer, liver cancer, or a type of lymphoma called DLBCL (Phase 2).
- Your doctor expects you to live for more than 12 weeks.
- You are well enough to carry out daily activities with little or no limitation (measured by a standard scale called ECOG, scoring 0 or 1).
- Your cancer can be measured on a scan using standard medical criteria.
- Your blood tests and other medical results fall within the ranges required by the study.
- For Phase 1: Your cancer has spread or is advanced, you have had at least one previous treatment, or there is no curative treatment available for your cancer.
- For Phase 2 (lung cancer): You have had at least one previous chemotherapy treatment containing platinum, and you have not previously received certain immunotherapy drugs (PD-1 or CTLA-4 targeted treatments).
- For Phase 2 (melanoma): Your BRAF gene mutation status has been documented; specific requirements depend on whether you are new to immunotherapy, did not respond to it, or responded but later relapsed (confirm with trial site).
- For Phase 2 (bladder/urinary tract cancer): Your cancer has spread or cannot be cured by surgery, and it has gotten worse during or after platinum-based chemotherapy.
- For Phase 2 (head and neck cancer): Your cancer has come back or spread and cannot be treated with surgery or radiation to cure it, and you have had at least one platinum-based chemotherapy treatment.
- For Phase 2 (ovarian cancer): You have a confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer at certain stages, and you have previously received a platinum and taxane-based chemotherapy as your first treatment.
- For Phase 2 (lymphoma/DLBCL): Your lymphoma has come back or stopped responding to treatment, you have had at least one previous treatment, and you are not a suitable candidate for a stem cell transplant or curative treatment.
- For Phase 2 (triple negative breast cancer): Your breast cancer has been confirmed as triple negative (testing negative for ER, PgR, and HER2), it cannot be surgically removed or has spread, and you have had at least one previous treatment for advanced disease.
- For Phase 2 (kidney cancer): Your kidney cancer is the clear cell type, cannot be cured by surgery, and you have previously received a treatment targeting blood vessel growth (anti-angiogenic therapy).
- For Phase 2 (bowel cancer/MSI high CRC): Your bowel cancer has spread or cannot be removed by surgery, has a specific genetic marker (MSI high), and you have had no more than two previous treatments for advanced disease.
- For Phase 2 (stomach cancer): Your stomach or stomach-oesophagus junction cancer has been confirmed by tissue or cell testing, and it has progressed after platinum or fluoropyrimidine-based treatment, or you declined standard treatment.
- For Phase 2 (liver cancer/HCC): Your liver cancer has been confirmed by tissue or cell testing, is at a specific stage of severity, you have had no more than two previous treatments, and you have previously tried, refused, or could not tolerate a drug called sorafenib.
- You are willing to provide a tissue sample (biopsy) for testing; in some cases, previously stored tissue may be acceptable (confirm with trial site).
- If you are a woman who could become pregnant, or a man, you are willing to use reliable contraception for at least 120 days after your last dose.
Who may not be able to join:
- You have taken part in another clinical trial and received an experimental drug or device within the past 2 weeks or 5 half-lives of that drug (whichever is longer) before starting this trial.
- You have previously been treated with certain immunotherapy drugs that target the immune system checkpoints (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
Incyte Corporation
Registry
clinicaltrials_gov
Start date
17 July 2014
Est. completion
26 November 2018
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events; Phase 2: Objective Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.