A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer (SKYSCRAPER-04)

Roche

Status and phase: Active, not recruiting; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Atezolizumab; Drug: Tiragolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04300647

2019-004895-21 (EudraCT Number)

WO42017

Details and patient eligibility

About

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).

Enrollment: 172 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Tiragolumab plus Atezolizumab

Experimental group

Description:

Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Treatment:

Drug: Tiragolumab

Drug: Atezolizumab

Atezolizumab

Experimental group

Description:

Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Treatment:

Drug: Atezolizumab