Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection

NCT05060003 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 202111158
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study's hypothesis is that patients with stage II melanoma who test positive for circulating tumor DNA are at a higher risk for recurrence and therefore adjuvant treatment is justified. In this study, the blood of consenting and eligible patients will be tested for ctDNA and those patients who test positive will be randomized on a 1:1 basis to either treatment with atezolizumab and tiragolumab or atezolizumab alone during Stage 1 of the study. If at least 3 patients in the atezolizumab + tiragolumab arm are shown to be ctDNA negative at C3D1, stage 2 of the study will begin enrollment. Stage 2 consists of 25 patients all enrolled to the atezolizumab + tiragolumab arm (no randomization and no atezolizumab monotherapy arm).Patients who test negative for ctDNA will be observed off protocol.

Conditions

Stage II Melanoma

Outcome Measures

Primary Outcomes (1)

• ctDNA Clearance Rate

  -Defined as the proportion of ctDNA-positive participants having a ctDNA-negative test at Cycle 3 Day 1

  Cycle 3 Day 1 (estimated to be 8 weeks)

Secondary Outcomes (8)

• Proportion of ctDNA-positive Participants Having a ctDNA-negative Test at Two Consecutive Measures

  From baseline to end of treatment (estimated to be 12 months)

• Relapse-free Survival (RFS)

  Through completion of follow-up (estimated to be 48 months)

• Distant Metastasis-free Survival (DMFS)

  Through completion of follow-up (estimated to be 48 months)

• Overall Survival (OS)

  Through completion of follow-up (estimated to be 48 months)

• Number of Treatment-related Grade 3 or Greater Adverse Events

  From start of treatment through 90 days after end of treatment (estimated to be 15 months)

Study Arms (2)

Arm 1: Atezolizumab + Tiragolumab

EXPERIMENTAL

* Atezolizumab is given as an IV infusion every 4 weeks at a dose of 1680 mg over 60 minutes (+/- 15 minutes). * Tiragolumab is given as an IV infusion every 4 weeks at a dose of 840 mg over 60 minutes (+/- 15 minutes). * Treatment can continue for up to 13 cycles.

Drug: Atezolizumab; Drug: Tiragolumab; Device: Signatera Assay

Arm 2: Atezolizumab

ACTIVE COMPARATOR

* Atezolizumab is given as an IV infusion every 4 weeks at a dose of 1680 mg over 60 minutes (+/- 15 minutes). * Treatment can continue for up to 13 cycles.

Drug: Atezolizumab; Device: Signatera Assay

Interventions

Atezolizumab DRUG

Atezolizumab is provided by Genentech.

Also known as: Tecentriq

Arm 1: Atezolizumab + Tiragolumab; Arm 2: Atezolizumab

Tiragolumab DRUG

Tiragolumab is provided by Genentech.

Arm 1: Atezolizumab + Tiragolumab

Signatera Assay DEVICE

* To detect residual disease or to determine cancer recurrence with ctDNA * Step 2 screening (4-12 weeks after date of surgery), cycle 3 day 1, cycle 6 day 1, cycle 9 day 1, cycle 12 day 1, and end of treatment (optional)

Arm 1: Atezolizumab + Tiragolumab; Arm 2: Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically resected and histologically/pathologically confirmed stage II cutaneous melanoma. No more than 16 weeks may elapse between final surgical resection and randomization. Treatment should start only after complete wound healing from the surgery.
• Participants must not have been previously treated for melanoma beyond complete surgical resection.
• At least 18 years of age.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease or malignancies in situ (such as DCIS), basal cell carcinoma, or localized cutaneous squamous cell carcinomas.
• Currently receiving any other investigational agents.
• Prior history of pneumonitis
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab and tiragolumab or other agents used in the study.
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the exceptions listed below:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover \< 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
• Active tuberculosis.
• Prior allogeneic stem cell or solid organ transplantation
• Positive hepatitis B surface antigen (HBsAb) at screening.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Melanoma

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: George Ansstas, M.D.
• Organization: Washington University School of Medicine

gansstas@wustl.edu

314-362-5677

Study Officials

• George Ansstas, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 28, 2021
• Study Start: November 8, 2022
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: February 20, 2024
• Results First Posted: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)