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NCT02298959
NCT02298959
Who may be able to join
Who might be able to join this trial:
- You have cancer that has spread to other parts of your body, confirmed by a tissue or cell sample — the specific cancer types allowed depend on which part of the trial you are entering (any solid tumor type for the early dose-finding phase; melanoma, kidney cancer, ovarian cancer, or colorectal cancer for expansion phase 1; treatment-resistant melanoma, treatment-resistant kidney cancer, or sarcoma for expansion phase 2)
- If you have kidney cancer, you must have already received at least one specific type of targeted drug treatment (a VEGF tyrosine kinase inhibitor)
- If you have ovarian cancer, your cancer must no longer be responding to platinum-based chemotherapy, and you must not have had more than two courses of platinum-based treatment
- If you have colorectal cancer, you must have already tried at least one treatment regimen containing a drug called oxaliplatin
- You have received no more than two previous treatments for your advanced cancer
- You are 18 years of age or older
- You are generally well enough to carry out light activity and care for yourself (your doctor will assess this using a standard fitness scale)
- Your doctor estimates you have more than 6 months to live
- Your blood counts and organ function (blood, liver, kidneys, and clotting) are within acceptable ranges, based on blood tests taken within 10 days of starting treatment
- Your urine protein levels are within an acceptable range
- A tissue sample from your tumor is available, either from previous tests or from a new biopsy
- Your cancer can be measured on a scan using standard criteria
- You are willing and able to use effective contraception (birth control) during the trial and for a set period after it ends (details below)
- If you are a woman who could become pregnant, you must have a negative pregnancy test within 24 hours before your first dose
- If you are a woman who could become pregnant, you must be willing to use two methods of birth control, or abstain from sex, throughout the trial and for 120 days after your last dose
- If you are a man, you must agree to use effective contraception during the trial and for 4 months after your last dose
- You are able to understand the trial and are willing to sign a consent form
- For expansion phase 2 (melanoma and kidney cancer only): your cancer must have grown or come back after treatment with a specific type of immunotherapy drug (an anti-PD-1 or anti-PD-L1 therapy)
- For expansion phase 2 (sarcoma only): you must have already received the standard recommended treatment for your sarcoma
Who may not be able to join:
- You have had chemotherapy, targeted therapy, or radiation therapy within the last 4 weeks (or 6 weeks for certain specific drugs), or you have not yet recovered from side effects of earlier treatment
- You are currently taking part in another clinical trial or have done so within the last 4 weeks
- You have a condition that weakens your immune system, or you are taking steroid or other immune-suppressing medicines within 7 days before starting the trial
- You have received a monoclonal antibody treatment within the last 4 weeks, or have not recovered from side effects of one
- You have another cancer that is actively growing or being treated (with some exceptions such as certain skin cancers or cervical changes that have been successfully treated)
- You have tumors in locations that your doctors consider to be at higher risk of bleeding, such as tumors growing into the wall of the bowel or certain lung tumors (confirm with trial site)
- You have open, ulcerated skin tumors
- You are currently taking Coumadin (warfarin) as a blood thinner (certain other blood thinners may be acceptable — confirm with trial site)
- Your blood pressure is poorly controlled (consistently above certain levels measured on separate days within the past 3 months)
- You are pregnant or breastfeeding
- You have active brain metastases (cancer that has spread to the brain) — however, if previously treated brain metastases have been stable for at least 3 months with no symptoms and no steroid use, you may still be eligible (confirm with trial site)
- You have cancer that has spread to the lining around the brain or spinal cord
- You have a known allergy to drugs similar to the ones being tested in this trial
- You have an active autoimmune disease (
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 1: approximately ~10% 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
Active, Not Recruiting
Phase
Phase 1
Sponsor
National Cancer Institute (NCI)
Registry
clinicaltrials_gov
Start date
8 April 2015
Est. completion
21 May 2025
Where this trial is recruiting
🇨🇦 Canada
🇺🇸 United States
Primary endpoints
Recommended combination dose of ziv-aflibercept and pembrolizumab
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.