A STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH IN PARTICIPANTS WITH MELANOMA THAT HAVE A GENETIC ABNORMALITY IN THE BRAF GENE.

Phase 1

• Conditions: Metastatic or unresectable locally advanced BRAF V600E/K mutation positive melanoma; MedDRA version: 20.0Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 100000004858; 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: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem 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 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10027150Term: Melanoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10027155Term: Melanoma skinSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10025665Term: Malignant melanoma of skin stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2020-004850-31-IT
• Lead Sponsor: PFIZER INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

1. Male or female participants = 18 years at the time of informed consent. Refer to protocol appendix 4 for reproductive criteria for male (protocol section 10.4.1) and female (protocol section 10.4.2) participants.
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition. Note: Locally advanced disease must not be amenable for treatment with curative intent.
4. Presence of at least 1 measurable lesion as detected by radiological and/or photographic methods according to RECIST v1.1. Note: Tumor lesions situated in a previously irradiated area, or in an
area subjected to other locoregional therapy, are not considered measurable unless there has been documented progression of the lesion. Note: If baseline scans from an institution other than the investigational
site are used, the site must obtain copies of the scans prior to enrolment of the participant, or the scans must be repeated at the investigational site and submitted for independent review (Phase 3 only). Note: Clinical lesions will only be considered measurable when they are superficial and = 10 mm diameter as assessed using calipers (eg, skin nodules). When lesions can be evaluated by both clinical exam and
imaging, imaging evaluation should be performed and submitted for independent review (Phase 3 only).
5. ECOG performance status 0 or 1.
For a full list please see protocol section 5.1
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 437
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 187

Exclusion Criteria

1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
2. Mucosal or ocular melanoma.
3. Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Participants with diabetes type I, vitiligo, psoriasis, controlled asthma, Graves' disease, Hashimoto's disease or hypo- or hyperthyroid disease are exceptions and may participate.
Note: Replacement and symptomatic therapies (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or
pituitary insufficiency) are not considered a form of immunosuppressive agents and are permitted.
4. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major,
linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
5. Unable to swallow, retain, and absorb oral medications.
For a full list please see section 5.2 of the protocol.

Study & Design

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