A Phase II Trial of Ipilimumab and Nivolumab for the Treatment of Rare Cancers (NCT02923934) | Clinical Trial Compass
CompletedPhase 2
A Phase II Trial of Ipilimumab and Nivolumab for the Treatment of Rare Cancers
Australia120 participantsStarted 2017-08-22
Plain-language summary
The three tumour streams that will be studied in this protocol are: (i) upper GI malignancies (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and (iii) rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours).
The role of immunotherapy is being defined in more common cancer types, however because of their rarity, the efficacy of immunotherapy for these cancers is poorly defined.
This protocol provides an important opportunity to establish whether the combination of nivolumab \& ipilimumab has efficacy in these cancers.
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
. Signed Written Informed Consent
. Target Population
. Age and Reproductive Status
Exclusion criteria
. Target Disease Exceptions
. Medical History and Concurrent Diseases
. Physical and Laboratory Test Findings
. Allergies and Adverse Drug Reaction
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
1
To determine the clinical efficacy of the combination treatment of ipilimumab with nivolumab in rare cancers.
Timeframe: at 12 weeks following randomisation then every 6 weeks until disease progression
Trial details
NCT IDNCT02923934
SponsorOlivia Newton-John Cancer Research Institute