A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Atezolizumab in Patients With NRAS-mutant Advanced Melanoma.

  • STATUS
    Recruiting
  • End date
    Nov 11, 2024
  • participants needed
    98
  • sponsor
    Genentech, Inc.
Updated on 12 July 2022
cancer
measurable disease
melanoma skin
NRAS
immunomodulators
cobimetinib
advanced melanoma
immunologic adjuvant
malignant melanoma of skin

Summary

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus atezolizumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

Description

The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm) of up to 15 patients; a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus atezolizumab arm (Belva + Cobi + Atezo arm) in a run-in phase followed by an expansion phase.

Details
Condition Melanoma
Treatment Cobimetinib, Atezolizumab, Belvarafenib
Clinical Study IdentifierNCT04835805
SponsorGenentech, Inc.
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ECOG Performance Status of 0 or 1
Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received up to two lines of systemic cancer therapy. Treatment with anti-PD-1/PD-L1 in the adjuvant setting is acceptable. Patients must have progressive disease at study entry
Documentation of NRAS mutation-positive within 5 years prior to screening
Tumor specimen availability
Adequate hematologic and end-organ function
Measurable disease per RECIST v1.1

Exclusion Criteria

Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1
Symptomatic, untreated, or actively progressing CNS metastases
History or signs/symptoms of clinically significant cardiovascular disease
Known clinically significant liver disease
History of autoimmune disease or immune deficiency
Prior treatment with a MEK inhibitor (cobimetinib arm)
History of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm)
History of immune-related AE attributed to prior anti-PD(L)1 therapy that resulted in permanent discontinuation of anti-PD(L)1 therapy (atezolizumab arm)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note