Neoadjuvant Atezolizumab for Melanoma

Overseen By Nestor Esnaola, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Methodist Hospital Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to see whether using atezolizumab before surgery is safe and does not cause side effects that delay surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk).

Research Team

Nestor Esnaola, MD

Principal Investigator

Houston Methodist Cancer Center

Eligibility Criteria

This trial is for adults with high-risk, non-metastatic cutaneous melanoma that can be surgically removed. Participants must have no prior treatments, good organ function, and a performance status of 0-2. They should not have had major surgery or live vaccines recently, nor should they have active infections or certain other health conditions.

Inclusion Criteria

My skin cancer is confirmed and still present after initial treatment.

My blood and organs are functioning well.

I do not have HIV, or if I do, it is under control with treatment.

Exclusion Criteria

I have or had an autoimmune disease or immune deficiency.

I have not had major surgery in the last 4 weeks.

I have had a previous transplant of stem cells or an organ.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Atezolizumab is administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles

6 weeks

2 visits (in-person)

Surgery

Participants undergo surgical resection after completing neoadjuvant atezolizumab treatment

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

63 months

Treatment Details

Interventions

• Atezolizumab

Trial Overview The study tests if atezolizumab given before surgery is safe and won't delay the procedure in patients with resectable cutaneous melanoma at high risk of recurrence post-surgery.

Participant Groups

Group I: Atezolizumab Experimental Treatment 1 Intervention

Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD