A study to investigate novel agent BNT111 and cemiplimab in combination or as single agents in patients with late stage skin cancer that has not responded to other forms of treatment.

Phase 1

• Conditions: Anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma; MedDRA version: 20.0Level: PTClassification code 10072449Term: Desmoplastic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 100000004858; MedDRA version: 20.0Level: PTClassification code 10024218Term: Lentigo malignaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10024220Term: Lentigo maligna recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10024223Term: Lentigo maligna stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10024224Term: Lentigo maligna stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2020-002195-12-IT
• Lead Sponsor: BioNTech SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients must have histologically confirmed unresectable Stage III or IV (metastatic) cutaneous melanoma and measurable disease by RECIST 1.1.
• Patients must have confirmed disease progression on/after approved anti-PD1 regimen for melanoma as defined by RECIST 1.1
• Previous exposure to approved anti-PD1 containing regimen for at least 12 consecutive weeks and
• Radiological progression to be confirmed by 2 scans 4-12 weeks apart. If progression is accompanied by new symptoms or deterioration of performance status not attributed to toxicity, one scan is sufficient.
• Progression must be while on treatment with approved anti-PD1 regimen for melanoma or within 6 months of discontinuing anti-PD1, and regardless of any intervening therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1.
• Patients must have serum lactate dehydrogenase (LDH) = ULN.

Please refer to the protocol for a full description of the inclusion criteria.
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 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

• History of uveal, acral, or mucosal melanoma.
• Ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events (irAEs). Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included.
• Systemic immune suppression within 14 days prior to randomization:
- Use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed); patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible,
- Other clinically relevant systemic immune suppression.

Please refer to the protocol for a full description of the exclusion criteria.

Study & Design

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