A Study of RO7247669 Alone or in Combination With Tiragolumab vs Atezolizumab in Participants With Untreated Locally Advanced or Metastatic Urothelial Cancer

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05645692
Collaborator
(none)
240
1
3
46.1
5.2

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of RO7247669 Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy
Anticipated Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Dec 30, 2026
Anticipated Study Completion Date :
Dec 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).

Drug: Atezolizumab
Participants will receive 1200 mg IV atezolizumab Q3W.

Experimental: Arm B

Participants will receive IV RO7247669 Q3W.

Drug: RO7247669
Participants will receive 600 mg IV RO7247669 Q3W.

Experimental: Arm C

Participants will receive IV RO7247669 + IV tiragolumab Q3W.

Drug: RO7247669
Participants will receive 600 mg IV RO7247669 Q3W.

Drug: Tiragolumab
Participants will receive 600 mg IV tiragolumab Q3W.

Outcome Measures

Primary Outcome Measures

  1. Confirmed Objective Response Rate (ORR) [Up to approximately 30 months]

Secondary Outcome Measures

  1. Progression-Free Survival (PFS) [Up to approximately 30 months]

  2. Overall Survival (OS) [Up to approximately 30 months]

  3. Duration of Response (DOR) [Up to approximately 30 months]

  4. PFS [6 months and 12 months]

  5. OS [6 months, 12 months, and 18 months]

  6. Disease Control Rate (DCR) [Up to 12 weeks]

  7. Time to Confirmed Deterioration (TTCD) [Baseline up to 3 weeks]

  8. Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores [Up to approximately 30 months]

  9. Maximum Concentration (Cmax) of RO7247669 [Up to approximately 30 months]

  10. Time of Maximum Concentration (Tmax) of RO7247669 [Up to approximately 30 months]

  11. Clearance (CL) of RO7247669 [Up to approximately 30 months]

  12. Volume of Distribution at Steady State (Vss) of RO7247669 [Up to approximately 30 months]

  13. Area Under the Curve (AUC) of RO7247669 [Up to approximately 30 months]

  14. Half-Life (T1/2) of RO7247669 [Up to approximately 30 months]

  15. Maximum serum concentration (Cmax) of tiragolumab [Up to approximately 30 months]

  16. Minimum serum concentration (Cmin) of tiragolumab [Up to approximately 30 months]

  17. Cmax of atezolizumab [Up to approximately 30 months]

  18. Cmin of atezolizumab [Up to approximately 30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

  • Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium

  • Ineligible ("unfit") to receive platinum-based chemotherapy

  • No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)

  • Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)

  • Availability of a representative leftover tumor specimen that is suitable for determination of PD-L1 status as assessed by a central laboratory

  • Adequate hematologic and end organ function

  • Negative for hepatitis B and hepatitis C virus (HCV)

  • Adequate cardiovascular function

Exclusion Criteria:
  • Pregnancy or breastfeeding

  • GFR <15 mL/min/1.73 m2

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

  • History of leptomeningeal disease

  • Uncontrolled tumor-related pain

  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

  • Uncontrolled or symptomatic hypercalcemia

  • Active or history of autoimmune disease or immune deficiency

  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

  • Active tuberculosis (TB) or Epstein-Barr virus (EBV)

  • Significant cardiovascular/cerebrovascular disease within 3 months prior to initiation of study treatment

  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study

  • History of another primary malignancy other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of malignancies with a negligible risk of metastasis or death

  • Severe infection within 4 weeks prior to initiation of study treatment

  • Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment

  • Prior allogeneic stem cell or solid organ transplantation

  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of RO7247669, or 90 days after the final dose of tiragolumab

  • Current treatment with anti-viral therapy for HBV

  • Treatment with any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment

  • Treatment with investigational therapy within 28 days prior to initiation of study treatment

  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-TIGIT and anti-LAG3 therapeutic antibodies or pathways targeting agents

  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment

  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment

  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing China 100142

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-LaRoche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT05645692
Other Study ID Numbers:
  • BO44157
First Posted:
Dec 9, 2022
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2023