drugset / Trial / NCT04225390
Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy
Phase 2
Completed
38 enrolled
University of Erlangen-Nürnberg Medical School
Ludwig-Maximilians - University of Munich · collabUniversity Hospital Regensburg · collabWuerzburg University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
PROMIT is a single arm phase 2 trial evaluating the clinical activity of immune checkpoint blockade (ICB) after administration of dacarbazine (DTIC) in patients with unresectable or metastatic, BRAF wildtype melanoma with primary resistance to anti-programmed-cell-death-1 (PD-1/PD-L1) or PD-1 plus anti-cytotoxic-T-lymphocyte antigen 4 (CTLA-4) blockade therapy. If the activity is clinically meaningful, DTIC could become a new therapeutic option to break primary resistance to immunotherapy.
Timeline
- Start
- 2020-01-13
- Primary completion
- 2026-01-15
- Completion
- 2026-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | 850 mg/m2 | Intravenous |
Indications
No indication recorded.