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UNKNOWNPHASE2

Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

Perioperative Encorafinib+Binimetinib in BRAFV600 Mutant Clinically Detected AJCC Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

NCT05097378•CCTU- Cancer Theme

View on ClinicalTrials.gov

Summary

A two-arm, randomised trial investigating the response of encorafenib and binimetinib compared to standard adjuvant therapy.

Detailed Description

A phase II, multi-centre, open label, randomised trial. The trial will assess the delivery, response rate, treatment compliance, efficacy and safety of encorafenib and binimetinib compared to standard adjuvant therapy in patients with BRAFV600 mutant clinically detected AJCC stage III(B/C/D) or oligometastatic stage IV Melanoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent to participate
•Aged ≥ 18 years old
•AJCC 8th edition stage III (B/C/D), or extracranial oligometastatic stage IV BRAFV600 mutant melanoma, based on histological/cytological and radiological assessments for which surgery is planned, and resection is expected to remove all known tumour(s) with R0 resection margins. 'Oligometastatic stage IV' is defined for the purpose of this trial as M stage disease confined to a single body organ excluding the brain that can be readily removed surgically with anticipated clear margins
•For stage III patients, confirmation of no evidence of distant metastatic disease using preferred imaging modalities including CT body or PET/CT and CT or MRI head
•For stage IV patients, confirmation of no evidence of unresectable metastatic disease, or metastatic disease in more than 1 body organ, using preferred imaging modalities including CT body or PET/CT and CT or MRI head. The site of metastasis should not be in bone, or CNS, or in any other body site where complete resection is not feasible
•The planned resectable disease must be radiologically measurable using standard imaging modalities.
•Baseline tumour assessments must be done within 28 days prior to randomisation
•BRAF V600E or V600K mutation confirmation
•Received no prior BRAF or MEK inhibitors
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
+16 more criteria

Exclusion Criteria

•Prior adjuvant therapy for resected primary or loco-regional melanoma
•Other invasive malignancies diagnosed within the last 2 years which are not in complete remission, or for which additional therapy is required
•Brain or bone metastases
•Non-cutaneous primary site of melanoma
•Prior radiotherapy to the site planned for surgery
•History or current evidence of retinal vein occlusion (RVO) or risk factors for RVO (uncontrolled glaucoma, ocular hypertension, history of hyperviscosity, or hypercoagulability syndromes)
•Left ventricular function \<50%
•Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the trial. Examples include, but are not limited to:
•Patients with uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction (MI), new angina, stroke transient ischaemic attack (TIA), or new congestive cardiac failure (CCF)) within the last 6 months
•Uncontrolled hypertension
+15 more criteria

Locations (1)

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Key Dates

Start Date

January 1, 2022

Primary Completion Date

September 1, 2023

Completion Date

January 31, 2024

Last Updated

October 28, 2021

Enrollment

ESTIMATED participants

Conditions

MelanomaCancer

Interventions

Encorafenib + Binimetinib

DRUG

Standard Adjuvant Treatment

DRUG

Contacts

Lisa Bax

CONTACT

+44 (0)1223 348090 lisa.bax@addenbrookes.nhs.uk

Sophie Twelves

CONTACT

sophie.twelves@addenbroookes.nhs.uk

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

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