Phase II Study of Atezolizumab and Tiragolumab With ctDNA for HPV-positive SCC

NCT06762808 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1479NCI-2024-10232
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single-arm, phase II study for patients with detectable HPV CtDNA at 12 weeks or longer after completion of definitive therapy for non-metastatic, HPV+ squamous cell carcinoma.

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Atezolizumab + Tiragolumab

EXPERIMENTAL

Treatment will be administered on an outpatient basis

Drug: Atezolizumab; Drug: Talazoparib

Interventions

Atezolizumab DRUG

Given by IV infusion

Atezolizumab + Tiragolumab

Talazoparib DRUG

Given by IV infusion

Atezolizumab + Tiragolumab

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed stage I-III HPV+ squamous cell carcinoma of the anus (anal canal, rectum, or anal margin), cervix, head \& neck, penis, vagina or vulva. An HPV/p16 status will be reviewed from outside testing if available or obtained on available tumor tissue as confirmed in a CLIA-certified environment within 28 days of enrollment.
• At least 12 weeks following completion of standard-of-care treatment with radiation and/or chemotherapy and/or surgical resection with curative intent, according to accepted standard practices for the disease site
• No clinical evidence of disease at the assessment of the treating investigator
• Detectable HPV ctDNA on a commercially available ctDNA assay or an MD Anderson-created HPV ctDNA assay at least 12 weeks following completion of curative-intent treatment
• Results of positive ctDNA test to confirm study eligibility may be performed within 42 days prior to enrollment
• Age ≥18 years
• Ability to understand and the willingness to sign a written informed consent document. A medical interpreter may be used when obtaining written informed consent
• Ability to comply with the study protocol
• ECOG performance status ≤2 (Karnofsky ≥60%).
• Adequate hematologic and end organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• ANC \>/= 1.0 x 109/L (1500/µL) without granulocyte colony-stimulating factor support.
• Lymphocyte count \> 0.5 x 109/L (500/µL).
• Platelet count \>/= 75 x 109/L (100,000/µL) without transfusion.
• Hemoglobin \>/= 90 g/L (9 g/dL). (Patients may be transfused to meet this criterion.)
• AST, ALT, and ALP \</= 2.5 x upper limit of normal (ULN).

You may not qualify if:

• Patients with a non-squamous cell carcinoma histology at the primary tumor type. Examples include, but are not limited to, adenocarcinoma, mixed adenosquamous carcinoma, melanoma.
• Patients with clinical, radiographic or pathologic evidence of squamous cell carcinoma at the time of study enrollment at the discretion of the treating investigator. An exception can be made for patients with radiographically measurable disease noted at the 12 week time point after completion of (chemo)radiation that is demonstrating an improvement/reduction in size at the discretion of the treating investigator consistent with treatment response.
• Uncontrolled or symptomatic hypercalcemia within 14 days of study registration (ionized calcium 1.5 mmol/L, calcium 12 mg/dL or corrected serum calcium ULN)
• Prior surgery as salvage treatment for radiation-refractory SCC.
• Patients who are receiving any other investigational agents or who received treatment with investigational therapy within 12 weeks prior to initiation of study treatment
• Patients who are receiving active therapy for cancer, including immunotherapy, chemotherapy, or radiotherapy. Participants should not have had received prior standard treatments within 12 weeks of study registration.
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.
• Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
• o 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 (see Appendix 8 for a more comprehensive list of autoimmune diseases and immune deficiencies), 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: i. Rash must cover \<10% of body surface area. ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroids. iii. There has been 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. iv. Active idiopathic pulmonary fibrosis or organizing pneumonia (e.g., bronchiolitis obliterans) on screening chest CT scan at the discretion of the treating investigator
• 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. Patients must be NYHA class 2B or better at the time of study registration.
• Major surgical procedure, within 4 weeks prior to initiation of study treatment
• History of malignancy other than HPV+ squamous cell carcinoma within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5 year OS rate \>90%), including but not limited to, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator
• Strategic Alliance: collaborator

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

atezolizumab; talazoparib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Emma Holliday, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 8, 2025
• Study Start: May 1, 2025
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08