Trials
Search / Trial NCT05661578

A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

Launched by HOFFMANN-LA ROCHE · Dec 15, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new treatment that combines two medications, tiragolumab and atezolizumab, given through an IV (intravenous) infusion. This study is specifically for adults with advanced solid tumors that have a specific marker called PD-L1. These tumors may be recurrent (coming back) or metastatic (spreading to other parts of the body), and participants must not have received prior similar treatments. The goal is to see how well this combination works and how it is processed by the body.

To be eligible for the trial, participants should be aged 18 or older, have a good performance status (meaning they can carry out daily activities), and have a life expectancy of at least 12 weeks. They should also have recovered from any side effects of previous cancer treatments, except for hair loss. Women who can become pregnant will need to have a negative pregnancy test and use contraception, while men must use condoms. During the trial, participants will receive the combination treatment and will be monitored for any side effects and the effectiveness of the therapy. It’s important for potential participants to discuss all available treatment options with their healthcare team before deciding to join this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy \>=12 weeks
  • Adequate hematologic and end organ function
  • Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia
  • For female participants of childbearing potential, negative serum pregnancy test within 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo
  • Cancer-Specific Inclusion Criteria:
  • Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
  • No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Submittal of archival tumor and/or fresh tumor tissue to the central laboratory for programmed death-1 (PD-L1) evaluation prior to enrollment
  • PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay
  • Exclusion Criteria:
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
  • Significant cardiovascular disease
  • Known clinically significant liver disease
  • Poorly controlled Type 2 diabetes mellitus
  • Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
  • Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
  • History of autoimmune disease
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
  • Cancer-Specific Exclusion Criteria:
  • Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation of study treatment
  • Prior treatment with immune checkpoint inhibitors (CPIs)
  • Less than 5 drug-elimination half-lives (\~100 days for typical monoclonal antibody \[Mab\]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
  • Less than 6 weeks between the last dose of prior immunomodulators and the proposed Day 1 of Cycle 1
  • Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
  • Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
  • Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred \</=6 months prior to Day 1 of Cycle 1
  • Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade \<=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy

Trial Officials

Clinical Trials

Study Director

Hoffmann-La Roche

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Valencia, , Spain

Barcelona, , Spain

Omaha, Nebraska, United States

Taipei, , Taiwan

Tianjin, , China

Taichung, , Taiwan

Taipei, , Taiwan

Taichung, , Taiwan

Sevilla, , Spain

Seoul, , Korea, Republic Of

Seongnam Si, , Korea, Republic Of

Seoul, , Korea, Republic Of

Pula, , Croatia

Valencia, , Spain

Belgrade, , Serbia

Montreal, Quebec, Canada

Ankara, , Turkey

Goyang Si, , Korea, Republic Of

Pikeville, Kentucky, United States

Sremska Kamenica, , Serbia

Spokane, Washington, United States

Seongnam Si, Gyeonggi Do, Korea, Republic Of

Pula, , Croatia

Seville, Sevilla, Spain

Barcelona, , Spain

Toronto, Ontario, Canada

Seoul, , Korea, Republic Of

Goyang Si, , Korea, Republic Of

Sremska Kamenica, , Serbia

Ankara, , Turkey

Tbilisi, , Georgia

Cordoba, , Spain

Taipei, , Taiwan

Belgrade, , Serbia

Patras, , Greece

Malatya, , Turkey

Tainan, , Taiwan

Cdmx, Mexico City (Federal District), Mexico

Zagreb, , Croatia

Ankara, , Turkey

Istanbul, , Turkey

Tbilisi, , Georgia

Belgrade, , Serbia

Chongqing City, , China

Fort Worth, Texas, United States

Athens, , Greece

Marousi, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Mexicali, Baja California, Mexico

Kladovo, , Serbia

Panorama, , Greece

Ankara, , Turkey

Tbilisi, , Georgia

Ankara, , Turkey

Malaga, , Spain

L?Hospitalet De Llobregat, Barcelona, Spain

Lemesos, , Cyprus

Strovolos, , Cyprus

Madrid, , Spain

Alt?Nova, , Turkey

Madrid, , Spain

Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of

Istanbul, , Turkey

Seyhan, , Turkey

Seyhan, , Turkey

Adana, , Turkey

Athens, , Greece

Athens, , Greece

Belgrade, , Serbia

Istanbul, , Turkey

Seyhan, , Turkey

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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