Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05768178
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-02-22
Brief Title:
DETERMINE Trial Treatment Arm 05 Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers
Sponsor:
Cancer Research UK
Organization:
Cancer Research UK
Study Overview
Official Title:
DETERMINE Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult Paediatric and TeenageYoung Adult TYA Cancers With Actionable Genomic Alterations Including Common Cancers With Rare Actionable Alterations Treatment Arm 05 Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETERMINE
Brief Summary:
This clinical trial is looking at a combination of drugs called vemurafenib and cobimetinib Vemurafenib is approved as standard of care for adult patients with unresectable or metastatic melanoma Cobimetinib is approved as standard of care in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma
Cobimetinib and vemurafenib work in patients with these types of cancers which have certain changes in the cancer cells called BRAF V600 mutation-positive
Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also BRAF V600 mutation-positive If the results are positive the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future
This trial is part of a trial programme called DETERMINE The programme will also look at other anti-cancer drugs in the same way through matching the drug to rare cancer types or ones with specific mutations
Cobimetinib and vemurafenib work in patients with these types of cancers which have certain changes in the cancer cells called BRAF V600 mutation-positive
Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also BRAF V600 mutation-positive If the results are positive the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future
This trial is part of a trial programme called DETERMINE The programme will also look at other anti-cancer drugs in the same way through matching the drug to rare cancer types or ones with specific mutations
Detailed Description:
DETERMINE Treatment arm 05 vemurafenib and Cobimetinib aims to evaluate the efficacy of vemurafenib and cobimetinib in adult patients with rare cancers with BRAF V600 mutations or in common cancers where BRAFV600 mutations and considered to be infrequent
Rare is defined generally as incidence less than 6 cases in 100000 patients or common cancers with rare alterations
This treatment arm has a target sample size of 30 evaluable patients Sub-cohorts may be defined and further expanded where promising activity is identified to a target of 30 evaluable patients each
The ultimate aim is to translate positive clinical findings to the NHS Cancer Drugs Fund to provide new treatment options for rare adult cancers
OUTLINE
Pre-screening The Molecular Tumour Board makes a treatment recommendation for the participant based on molecularly-defined cohorts
Screening Consenting participants undergo biopsy and collection of blood samples for research purposes
Treatment Participants will receive vemurafenib and cobimetinib until disease progression unacceptable toxicity or withdrawal of consent Participants will also undergo collection of blood samples at various intervals while receiving treatment and at EoT
After completion of study treatment patients are followed up every 3 months for 2 years
THE DETERMINE TRIAL MASTER SCREENING PROTOCOL
Please see DETERMINE Trial Master Screening Protocol record NCT05722886 for information on the DETERMINE Trial Master Protocol and applicable documents
Rare is defined generally as incidence less than 6 cases in 100000 patients or common cancers with rare alterations
This treatment arm has a target sample size of 30 evaluable patients Sub-cohorts may be defined and further expanded where promising activity is identified to a target of 30 evaluable patients each
The ultimate aim is to translate positive clinical findings to the NHS Cancer Drugs Fund to provide new treatment options for rare adult cancers
OUTLINE
Pre-screening The Molecular Tumour Board makes a treatment recommendation for the participant based on molecularly-defined cohorts
Screening Consenting participants undergo biopsy and collection of blood samples for research purposes
Treatment Participants will receive vemurafenib and cobimetinib until disease progression unacceptable toxicity or withdrawal of consent Participants will also undergo collection of blood samples at various intervals while receiving treatment and at EoT
After completion of study treatment patients are followed up every 3 months for 2 years
THE DETERMINE TRIAL MASTER SCREENING PROTOCOL
Please see DETERMINE Trial Master Screening Protocol record NCT05722886 for information on the DETERMINE Trial Master Protocol and applicable documents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRAS ID 1004057 | OTHER | IRAS | None |