Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC (NCT07765836) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC
United States40 participantsStarted 2027-01
Plain-language summary
This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient pancreatic cancer (PC).
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:
* Participant must have histologically proven metastatic pancreatic cancer. Histologies including acinar cell carcinoma, carcinoma, ductal carcinoma, ductal adenocarcinoma, poorly differentiated or adenosquamous carcinoma are allowed.
* Participant must have a germline or somatic pathogenic alteration in BRCA1, BRCA2, or PALB2 on tumor next generation sequencing (NGS) performed using a CLIA certified assay. Somatic pathogenic alterations detected on circulating tumor DNA need confirmation on tumor tissue NGS. Germline pathogenic alterations in BRCA1, BRCA2 or PALB2 do not require further confirmation on tumor NGS. All genomic reports be verified in writing (via email) by site and/or overall PI.
* Participants must have measurable disease per RECIST version 1.1.
* Participant must have at least one disease site which is amenable to safe biopsy and must agree to pre- and on-treatment biopsies (core, incisional, or excisional biopsy) of tumor site. In select cases biopsies can be waived after discussion with the Sponsor Investigator.
* Participant must have had at least one but not more than two lines of cytotoxic chemotherapy for metastatic disease. Receipt of neoadjuvant or adjuvant therapy within the last 12 months may count as one line of therapy in metastatic setting for patients with recurrent disease who are being considered for the study. Receipt of targeted therapy such as KRAS inhibitor, or PARP inhibitor is not counted line of therapy. Recycling o…
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.