Clinical trial · Interventional
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Tiragolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tiragolumab plus Atezolizumab
- description
- Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- interventionNames
- Drug: Tiragolumab
- Drug: Atezolizumab
- type
- EXPERIMENTAL
- label
- Atezolizumab
- description
- Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- interventionNames
- Drug: Atezolizumab
Primary outcomes (1)
- measure
- Pre-crossover Period: Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSalani R, McCormack M, Kim YM, Ghamande S, Hall SL, Lorusso D, Barraclough L, Gilbert L, Guzman Ramirez A, Lu CH, Sabatier R, Colombo N, Hu Y, Krishnan V, Molinero L, Feng Y, Kim N, Castro M, Lin YG, Monk BJ. A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04). Int J Gynecol Cancer. 2024 Aug 5;34(8):1140-1148. doi: 10.1136/ijgc-2024-005588. PMID 38858106