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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Step One (Signatera Assay Development)

Inclusion Criteria:

  • - 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).
Step One (Signatera Assay Development)

Exclusion Criteria:

  • - 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.
  • - Positive hepatitis C virus (HCV) antibody test at screening (unless followed by a negative HCV RNA test).
  • - Current treatment with anti-viral therapy for HBV.
  • - Positive Epstein-Barr virus (EBV) viral capsid antigen immunoglobulin M (IgM) test at screening.
An EBV PCR test should be performed as clinically indicated to screen for acute infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded.
  • - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies.
  • - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • - Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration.
Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Step Two (Randomization and Treatment)

Inclusion Criteria:

  • - Positive ctDNA test.
  • - Normal bone marrow and organ function as defined below: - Absolute neutrophil count ≥ 1,500/mcL.
  • - Lymphocyte count ≥ 500/mcL.
  • - Platelets ≥ 100,000/mcL.
  • - Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion) - Total bilirubin ≤ 1.5 x IULN or direct bilirubin ≤ IULN for participants with total bilirubin levels > 1.5 x IULN; patients with known Gilbert disease must have total bilirubin ≤ 3 x IULN.
  • - AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN.
  • - Alkaline phosphatase ≤ 2.5 x IULN.
  • - Creatinine clearance ≥ 45 mL/min by Cockcroft-Gault.
  • - Serum albumin ≥ 2.5 g/dL.
  • - INR or PT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • - aPTT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • - ECOG performance status ≤ 1.
  • - The effects of atezolizumab and tiragolumab on the developing human fetus are unknown.
For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation, for 90 days after the final dose of tiragolumab, and for 5 months after the final dose of atezolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 90 days after completion of the study. Step Two (Randomization and Treatment)

Exclusion Criteria:

  • - Pregnant and/or breastfeeding.
Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • - Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment, within 90 days after the final dose of tiragolumab, or within 5 months after the final dose of atezolizumab.
  • - Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.
  • - Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α [TNF-α] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: - Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
  • - Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
  • - Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
  • - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety.
  • - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.
Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • - Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05060003
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

George Ansstas, M.D.
Principal Investigator Affiliation Washington University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Stage II Melanoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Arm 1: Atezolizumab + Tiragolumab

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.

Active Comparator: Arm 2: Atezolizumab

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.

Interventions

Drug: - Atezolizumab

Atezolizumab is provided by Genentech.

Drug: - Tiragolumab

Tiragolumab is provided by Genentech.

Device: - Signatera Assay

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Not yet recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Yan Xing, M.D., Ph.D.

[email protected]

626-256-4673

University of California - San Francisco, San Francisco, California

Status

Not yet recruiting

Address

University of California - San Francisco

San Francisco, California, 94143

Site Contact

Adil Daud, M.D.

[email protected]

415-353-9900

Yale School of Medicine, New Haven, Connecticut

Status

Not yet recruiting

Address

Yale School of Medicine

New Haven, Connecticut, 06510

Site Contact

Mario Sznol, M.D.

[email protected]

203-200-6622

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

George Ansstas, M.D.

[email protected]

314-362-5677

Memorial Sloan Kettering, New York, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering

New York, New York, 10065

Site Contact

Margaret Callahan, M.D., Ph.D.

[email protected]

646-888-5108

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Not yet recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Site Contact

Meredith McKean, M.D., MPH

[email protected]

615-329-7274

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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