Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy (PROMIT)

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Melanoma

• Registration Number: EUCTR2017-003556-23-DE
• Lead Sponsor: niversity Hospital of the Friedrich-Alexander University Erlangen-Nürnberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-04
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Key inclusion criteria:
1. Histologically confirmed metastatic melanoma
2. Progression after checkpoint inhibitor therapy (anti-PD-1/PD-L1 containing regimens)
3. Accessible tumor metastases
4. ECOG 0 or 1
5. Adequate organ function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

Key exclusion criteria:
1. Uvea melanoma, mucosal melanoma
2. Previous chemotherapy in metastatic disease
3. Previous response to checkpoint inhibitor therapy (regimen containing PD-1 or PD-L1 inhibitors) in metastatic disease
4. BRAF V600 mutation
5. Active brain metastases or autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified