Phase 2
Completed N=172
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Source: ClinicalTrials.gov NCT04300647 ↗Enrolled (actual)
172
Serious AEs
29.3%
Results posted
Feb 2025
Primary outcomePrimary: Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) — 15.6; 19.0 percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR) |
15.6; 19.0 | — |
| SECONDARY Pre- and Post-crossover Periods: Number of Participants With Adverse Events (AEs) |
41; 118; 14 | — |
| SECONDARY Pre-crossover Period: IRC-assessed Duration of Response (DOR) |
NA; 11.8 | — |
| SECONDARY Pre-crossover Period: IRC-assessed Disease Control Rate (DCR) |
20.0; 31.0 | — |
| SECONDARY Pre-crossover Period: Investigator-assessed Best Clinical Response (BCR) Rate |
33.3; 44.4 | — |
| SECONDARY Pre-crossover Period: Investigator-assessed Duration of BCR |
7.0; 5.5 | — |
| SECONDARY Pre-crossover Period: IRC-assessed Progression-free Survival (PFS) |
1.9; 2.8 | — |
| SECONDARY Pre-crossover Period: IRC-assessed PFS Rate at 6 Months |
21.50; 30.56 | — |
| SECONDARY Pre-crossover Period: Overall Survival (OS) |
10.6; 11.0 | — |
| SECONDARY Pre-crossover Period: OS Rate at 6 Months and 12 Months |
69.49; 73.56; 37.88; 47.19 | — |
| SECONDARY Pre-crossover Period: Minimum Serum Concentration (Cmin) of Tiragolumab |
33.0; 49.3; 58.9; 80.5; 83.7; 92.7 | — |
| SECONDARY Pre-crossover Period: Maximum Serum Concentration (Cmax) of Tiragolumab |
226 | — |
| SECONDARY Pre-crossover Period: Cmin of Atezolizumab |
89.8; 89.4; 139; 137; 175; 156 | — |
| SECONDARY Pre-crossover Period: Cmax of Atezolizumab |
522; 507 | — |
| SECONDARY Pre-crossover Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab |
0.0 | — |
| SECONDARY Pre-crossover Period: Percentage of Participants With ADAs to Atezolizumab |
20.0; 11.2 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
- Radiologically-measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
- Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
- Life expectancy of at least 12 weeks
- Adequate hematologic and organ function
- Female of childbearing potential must be willing to comply with adequate contraception
Exclusion Criteria
- Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
- Active or untreated central nervous system (CNS) or brain metastases
- Active or history of autoimmune disease or immune deficiency
- Active tuberculosis
- Known, clinically significant liver disease
- Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
- Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study
- Pregnant or breastfeeding woman
- Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations
Data sourced from ClinicalTrials.gov (NCT04300647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.