← Back to Search

Kinase Inhibitor

Drug Combinations for Colorectal Cancer

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have a BRAF V600 mutation confirmed by local assessment.

Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease

Must not have

History of or current interstitial lung disease or non-infectious pneumonitis

Clinically significant cardiac disease at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 34 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and tolerability of different combinations of drugs in order to find the best doses and regimens for future studies.

Who is the study for?

Adults with advanced/metastatic BRAF V600 colorectal cancer who've had disease progression after 1-2 chemotherapy lines or are intolerant to them. Participants must be willing to undergo tumor biopsies and have a confirmed BRAF V600 mutation. Excluded are those with significant heart issues, gastrointestinal conditions affecting drug absorption, certain eye diseases, HIV, other active cancers (with exceptions), lung diseases, or pregnant/breastfeeding women.

What is being tested?

The trial is testing combinations of drugs LXH254, Dabrafenib, Spartalizumab, Tislelizumab, TNO155, Trametinib and LTT462 in adults with specific colorectal cancer. It's an early-phase study aiming to find out the safest doses for future research by monitoring participants' reactions.

What are the potential side effects?

Potential side effects may include typical reactions seen with cancer treatments such as nausea, fatigue, skin changes and increased risk of infections. Specific side effects will depend on the drug combination received but can also involve risks related to immune system responses or organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has a BRAF V600 mutation.

Select...

My cancer has worsened after 1 or 2 chemotherapy treatments, or I couldn't tolerate the treatment.

Select...

My colon or rectum cancer cannot be surgically removed and has a specific mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or had lung inflammation not caused by an infection.

Select...

I have a serious heart condition.

Select...

I have a stomach or intestine problem that affects how I absorb medication.

Select...

I have or am at risk for eye vein blockage or fluid build-up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 34 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~34 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose intensity

Frequency of dose interruptions

Frequency of dose reductions

+2 more

Secondary study objectives

AUClast derived from Serum/plasma concentration of individual investigational drugs within combination treatments

AUCtau derived from Serum/plasma concentration of individual investigational drugs within combination treatments

Best overall response (BOR)

+7 more

Side effects data

From 2021 Phase 3 trial • 552 Patients • NCT03551626

68%

Pyrexia

32%

Headache

30%

Blood creatine phosphokinase increased

27%

Diarrhoea

26%

Fatigue

26%

Chills

24%

Asthenia

23%

Nausea

21%

Arthralgia

21%

Rash

15%

Vomiting

15%

Myalgia

14%

Alanine aminotransferase increased

14%

Cough

13%

Lipase increased

13%

Aspartate aminotransferase increased

12%

Influenza like illness

12%

Oedema peripheral

Pain in extremity

Neutropenia

Abdominal pain

Constipation

Muscle spasms

Back pain

Blood alkaline phosphatase increased

Decreased appetite

Hypophosphataemia

Dyspnoea

Erythema

Hypertension

Amylase increased

Hyperglycaemia

Dry skin

Dizziness

Abdominal pain upper

Pain

Pruritus

Oropharyngeal pain

Ejection fraction decreased

Atrial fibrillation

Erysipelas

Cellulitis

Basal cell carcinoma

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Dabrafenib+Trametinib (On-treatment)

Dabrafenib+Trametinib (Post-treatment Follow-up)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.