Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG (NCT07644312) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG
12 participantsStarted 2027-03-01
Plain-language summary
The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.
Who can participate
Age range
12 Years – 39 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:
* Patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR.
* Within the United States, patients must weight ≥ 40 kg at the time of enrollment. For all other countries, patients must weight ≥ 30 kg at the time of enrollment.
Diagnosis:
* Patients with newly-diagnosed HGG, including DIPG, are eligible. All patients mut have histologic confirmation from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG must have been confirmed through TarGeT-SCR.
* All HGGs must be WHO Grade 3 or 4. Note: WHO Grade 2 gliomas with pontine epicenter and diffuse involvement of at least 2/3 of the pons are eligible.
Disease Status:
* Patients must be newly diagnosed.
* Measurable disease is not required.
* Patients with primary spinal tumors are eligible.
* Patients should have no evidence of herniation or impending herniation, and no mass effect leading to severe midline shift.
* Patients with prior malignancy are eligible.
* Metastatic disease is excluded.
* Disseminated or multifocal disease: discussion with Study Chairs is required. Patients with multifocal disease who received upfront CSI are not eligible.
Demonstration of DNA replication repair deficiency (RRD) by fulfilling at least 2 of the following criteria:
* Tumor mutational burden greater than or equal to 5 mutations/megabase (Intermediate and high TMB)
* Genetic diagnosis of germline Constitutional Mismatch Repair Deficiency (CMMRD), Lynch Syndrome, or Polyme…
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.
1My tumor has been identified as replication repair deficient — does that specific molecular feature make this trial worth considering for my situation, or are there other treatment paths that might be a better fit first?
2This trial is Phase 2 and hasn't started enrolling yet — given that it's still in an early phase and not yet open, how does that uncertainty around safety and benefit affect whether we should wait for it or pursue other options now?
3The trial is specifically measuring how many patients experience immune-related side effects from this combination of relatlimab and nivolumab — what kinds of immune-related reactions should I be prepared to watch for, and how are those typically managed in brain tumor patients?
4One of the key things being measured is whether patients can get through the first three cycles of maintenance therapy without needing to reduce or stop their doses — what does that treatment schedule actually look like week-to-week, and is that realistic given my current health and daily life?
5Since this trial covers both high grade glioma and DIPG, which can be very different diagnoses, can you help me understand whether the specific type and location of my tumor makes this combination immunotherapy approach a reasonable option to discuss pursuing?
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
Number of Participants with Adverse Events, Immune Related Adverse Events, and Dose Modifying Toxicities as assessed by CTCAE v6
Timeframe: 4 years
2
Number of participants that complete the first 3 cycles of maintenance therapy without experiencing dose modifying toxicities