Neoadjuvant Atezolizumab for Melanoma

Overseen By Nestor Esnaola, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Antibiotics, Immunosuppressants, Anticoagulants, others

Disqualifiers: Autoimmune disease, Cardiovascular disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if atezolizumab, an immune therapy, is safe for use before surgery in individuals with cutaneous melanoma, a specific type of skin cancer. The focus is on cases where the cancer hasn't spread, can be surgically removed, but has a high risk of recurrence. Participants should have a diagnosis of this untreated, high-risk melanoma.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as systemic immunosuppressive medications and therapeutic antibiotics, at least 2 weeks before starting the trial. If you are on antiviral therapy for hepatitis B or using anticoagulants at therapeutic levels, you may also need to stop these medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that atezolizumab is likely to be safe for humans?

Research has shown that atezolizumab is usually well-tolerated by patients. In one study, only 5.9% of patients experienced serious side effects potentially related to the treatment. Atezolizumab is already used for other conditions, which gives doctors some confidence in its safety. However, since this trial is in an early stage, much remains to be learned about its safety for treating melanoma. Overall, the early results are promising, but ongoing research will provide more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Atezolizumab is unique because it harnesses the body's immune system to fight melanoma by targeting the PD-L1 protein, which helps cancer cells evade immune detection. Unlike traditional treatments like surgery, radiation, or chemotherapy, Atezolizumab works by boosting the immune response, potentially leading to more durable outcomes. Researchers are excited about its potential for fewer side effects and its ability to offer a new lifeline for patients with advanced melanoma, especially in cases where other treatments might not be effective.

What evidence suggests that atezolizumab might be an effective treatment for melanoma?

Studies have shown that using atezolizumab before surgery, known as neoadjuvant therapy, can be promising for patients with high-risk melanoma. In this trial, participants will receive atezolizumab as neoadjuvant therapy. Research indicates that this approach can lead to significant tumor shrinkage in 47% of patients, which is a positive sign. Additionally, one trial reported that 73.3% of patients remained cancer-free a year after surgery. These findings suggest that atezolizumab might help make the cancer more manageable before surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Nestor Esnaola, MD

Principal Investigator

Houston Methodist Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40795522/

Phase II trial of neoadjuvant atezolizumab and tiragolumab ... Among patients with high-risk resectable Stage III melanoma, neoadjuvant atezolizumab/tiragolumab was a promising regimen with a favorable ...

2. ejcancer.com ejcancer.com/article/S0959-8049(25)00470-8/fulltext

Phase II trial of neoadjuvant atezolizumab and tiragolumab ... Neoadjuvant immunotherapy has recently been shown to have improved efficacy compared with adjuvant therapy alone for melanoma patients with ...

3. emjreviews.com emjreviews.com/dermatology/news/neoadjuvant-immunotherapy-in-stage-iii-melanoma/

Neoadjuvant Immunotherapy in Stage III Melanoma The trial reported a major pathological response (MPR) rate of 47%, which compares favourably to monotherapy with pembrolizumab and is only ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.9503

NeoACTIVATE arm C: Phase II trial of neoadjuvant ... With 16 months median follow-up from operation, 12-month RFS was 73.3% (n=28, 95% CI 56.9 to 94.5%), while 12-month DMFS was 86.0% (n=28, 95% CI ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12001372/

Neoadjuvant cobimetinib and atezolizumab with or without ... We tested neoadjuvant treatment with 12 weeks of vemurafenib, cobimetinib, and atezolizumab for patients with BRAF-mutated (BRAFm) melanoma (cohort A)

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02927301

NCT02927301 | A Study of Atezolizumab as Neoadjuvant ... This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer ...

7. nature.com nature.com/articles/s41467-024-45798-8

the Phase II NeoACTIVATE trial In this study, we test 12 weeks of neoadjuvant treatment with either vemurafenib, cobimetinib, and atezolizumab (in patients with BRAFm melanoma ...