A Phase 2, single arm study on dacarbazine (DTIC) followed by immunotherapy re-challenge in unresectable or metastatic melanoma with primary resistance to PD-1/PD-L1 or PD-1 + CTLA-4 blockade (PROMIT: PReconditioning of TumOr, Tumor Microenvironment and the Immune System to ImmunoTherapy)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517065-16-00

Acronym

PROMIT

Enrollment

Registered

2024-11-14

Start date

2020-01-13

Completion date

2026-01-15

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

Overall response rate (ORR) at week 14 according to RECIST 1.1 in all patients receiving at least on. A patient is defined as responder if a complete response (CR) or partial response (PR) can be seen. A patient with stable disease (SD) or progressive disease (PD) will be defined as non-responder., Overall survival (OS), defined as the time between study inclusion and date of death (any cause).

Detailed description

Collect biological samples (tissue/blood/stool) to assess immunological changes, Quality of life assessed by EORTC QLQ-C30

Interventions

DRUGPEMBROLIZUMAB

DRUGNIVOLUMAB

DRUGIPILIMUMAB

DRUGDACARBAZINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Collect biological samples (tissue/blood/stool) to assess immunological changes, Quality of life assessed by EORTC QLQ-C30	—

Primary

Measure	Time frame
Overall response rate (ORR) at week 14 according to RECIST 1.1 in all patients receiving at least on. A patient is defined as responder if a complete response (CR) or partial response (PR) can be seen. A patient with stable disease (SD) or progressive disease (PD) will be defined as non-responder., Overall survival (OS), defined as the time between study inclusion and date of death (any cause).	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026