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Clinical Trials/EUCTR2020-002195-12-IT
EUCTR2020-002195-12-IT
Active, not recruiting
Phase 1

An open-label, randomized Phase II trial with BNT111 and cemiplimab in combination or as single agents in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma -

BioNTech SE0 sites120 target enrollmentStarted: May 20, 2021Last updated:
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ConditionsAnti-PD1-refractory/relapsed, unresectable Stage III or IV melanomaMedDRA 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: 100000004858MedDRA 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)MedDRA version: 20.0Level: PTClassification code 10066600Term: Melanoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 100Therapeutic area: Diseases [C] - Cancer [C04]
DrugsLibtayo

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
120
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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:

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.

Investigators

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