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Nivolumab +/- Ipilimumab for Ovarian Cancer
Study Summary
This trial is testing whether a new drug can help people with a certain type of ovarian cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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- My ovarian, fallopian, or peritoneal cancer worsened after platinum and taxane treatment.My clear cell cancer has worsened after at least one treatment for its advanced stage.My total bilirubin levels are within the normal range, or I have Gilbert's syndrome or liver metastases with specific limits.You have had a serious allergic reaction to any type of medication called monoclonal antibodies.I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.I am using highly effective birth control as a woman able to have children.I have previously received treatments targeting the immune system for cancer.I do not have brain metastases.I haven't had any cancer except for non-melanoma skin cancer in the last 3 years.My cancer is a type of clear cell carcinoma and has come back or spread.I have at least one cancer lesion that can be measured.I have never been treated with anti-PD-1, PD-L1, or CTLA-4 antibodies.I am 18 years old or older.I am fully active or can carry out light work.I have not had chemotherapy in the last 3 years, except for clear cell cancer.I have HIV/AIDS, am on stable HAART, have CD4 counts > 350, and no detectable viral load.I had hepatitis but have been treated for 6 months, have no detectable virus, and my liver tests are normal.My thyroid function is normal, or controlled with medication.I am a man and will use highly effective birth control if I'm sexually active with a woman who can become pregnant.I do not have an active autoimmune disease or a history that could affect my organs.My kidney function, measured by creatinine levels or clearance, is within normal limits.You are not allowed to be taking any other experimental drugs.I have recovered from major side effects of previous treatments.I am a man and will use birth control for 7 months after treatment if sexually active with a woman who can become pregnant.I am not planning to receive any other cancer treatments not part of the trial.I have moderate to severe numbness, pain, or weakness in my hands or feet.My organ and bone marrow functions are normal.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or nitrosoureas/mitomycin C in the last 6 weeks.I do not have any serious ongoing illnesses that my doctor is currently treating.I am not able to have children due to menopause or surgery.
- Group 1: Arm 1 Nivolumab Ovarian
- Group 2: Arm 2 Nivolumab and Ipilimumab Ovarian
- Group 3: Arm 1 Nivolumab Extra-renal
- Group 4: Arm 2 Nivolumab and Ipilimumab Extra-renal
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are applications being accepted for this medical trial at present?
"Affirmative. Clinicaltrials.gov has information verifying that this trial is currently recruiting 62 participants from 4 different sites, with the original posting date being April 30th 2018 and most recent update on May 12th 2022."
What other evidence do we have of Nivolumab's efficacy in clinical settings?
"At the present moment, there are 765 studies involving Nivolumab in progress with 86 of those trials at Phase 3. While Pittsburgh is one hub for these experiments, multiple other locations across 42755 cities are currently conducting research on this drug."
What diseases have been improved by the use of Nivolumab?
"Nivolumab offers a possible therapeutic option for those with past anti-angiogenic therapy, malignant neoplasms, or inoperable melanoma."
Has Nivolumab been given clearance by the Food and Drug Administration?
"By our estimation, the safety of Nivolumab has been rated a 2 due to evidence supporting its security but no proof that it is efficacious."
How many participants have signed up for the trial thus far?
"Affirmative. The info on clinicaltrials.gov indicates that recruitment for this experiment is ongoing and has been since April 30th 2018 when it was first posted and updated most recently on May 12th 2022. 62 patients are required from 4 different medical centres."
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