Nivolumab Post Treatment with Ide-Cel
Nivolumab As An Adjunctive Therapy In Relapsed Refractory Multiple Myeloma Patients With Sub-Optimal Response To Idecabtagene Vicleucel
What will happen during the trial?
This is a single arm, two-stage, Phase II of adjuvant nivolumab in patients with RRMM treated with at least 2 prior lines of therapy and are refractory to or intolerant of at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 antibody who achieved a sub-optimal response (defined as a VGPR, PR, MR, or SD by IMWG 2016 criteria) to treatment with idecabtagene vicleucel.
Our study will determine best overall response after 2 cycles of adjuvant nivolumab given every 4 weeks in patient who achieve a sub-optimal response to ide-celon restaging studies ~30 days after infusion. We will also evaluate for changes in CAR-T cell expansion, persistence of CAR-T cells, and additional toxicity compared to historical controls.
More Information
- Trial Status
- Not yet accepting
- Trial Phase
- Phase 2
- Enrollment
- 50 patients (estimated)
- Sponsors
- Wake Forest University Health Sciences
- Collaborators
- Atrium Health's Levine Cancer Institute - Charlotte (Main), Bristol Myers Squibb
- Tags
- Checkpoint Inhibitor, Monoclonal Antibody, Programmed Death Receptor-1 (PD-1), Post-CAR T
- Trial Type
- Treatment
- Last Update
- 2 weeks ago
- SparkCures ID
- 1972
- NCT Identifier
- NCT06523621
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