Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: University Hospital Regensburg; Wuerzburg University Hospital
• Treatments: Dacarbazine

Criteria

Inclusion Criteria:

1. Histologically confirmed metastatic melanoma

2. Progression after checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade)

3. Accessible tumor metastases

4. ECOG 0 or 1

5. Adequate organ function

Exclusion Criteria:

1. Uvea melanoma, mucosal melanoma

2. Previous chemotherapy in metastatic disease

3. Previous response to checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) in metastatic disease

4. BRAF V600 mutation

5. Active brain metastases

6. Autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs