NCT04225390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

January 3, 2020

Last Update Submit

February 6, 2026

Conditions

Immunotherapy

Keywords

immune checkpoint blockaderesistancedacarbazine

Outcome Measures

Primary Outcomes (1)

  • Rate of participents with CR, PR, SD or PD

    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.

    week 14

Secondary Outcomes (1)

  • Overall survival (OS)

    up to 5 years

Study Arms (1)

Dacarbazine

EXPERIMENTAL

Dacarbazine (day1 and day21) 850 mg/m² i.v. followed by re-exposure to the previous immunotherapy

Drug: Dacarbazine (DTIC)

Interventions

Dacarbazine (DTIC)DRUG

Dacarbazine powder for IV solution

Also known as: DTIC
Dacarbazine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed metastatic melanoma
  • Progression after checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade)
  • Accessible tumor metastases
  • ECOG 0 or 1
  • Adequate organ function

You may not qualify if:

  • Uvea melanoma, mucosal melanoma
  • Previous chemotherapy in metastatic disease
  • Previous response to checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) in metastatic disease
  • BRAF V600 mutation
  • Active brain metastases
  • Autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Interventions

Dacarbazine

Intervention Hierarchy (Ancestors)

TriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 13, 2020

Study Start

January 13, 2020

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

February 10, 2026

Record last verified: 2026-01

Locations

DE(1)