A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer

ClinicalTrials.gov Identifier: NCT04294160

Novartis Reference Number: CADPT01C12101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

Condition 
BRAF V600 Colorectal Cancer
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
280 participants
Start date 
Jul 22, 2020
Completion date 
Feb 28, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Dabrafenib
Capsule for oral use
Drug
LTT462
Capsule for oral use
Drug
Trametinib
Tablet for oral use
Drug
LXH254
Tablet for oral use
Drug
TNO155
Capsule for oral use
Biological
Spartalizumab
Liquid in vial (Concentrate for solution for infusion) for intravenous use

Eligibility Criteria

Key Inclusion Criteria:

Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
All patients must have a BRAF V600 mutation confirmed by local assessment.
Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease

Key Exclusion Criteria:

Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
History of or current evidence/risk of retinal verin occlusion or serous retinopathy
History of or current interstitial lung disease or non-infectious pneumonitis
Patients with a known history of testing positive for HIV
Clinically significant cardiac disease at screening
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Pregnant or lactating women

Study Locations

Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]