Clinical trial · Interventional
Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent 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)
This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients: Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w
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 |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- atezolizumab monotherapy
- description
- A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
- interventionNames
- Drug: Atezolizumab
- type
- EXPERIMENTAL
- label
- atezolizumab combined with doxorubicin
- description
- A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle. Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease
- interventionNames
- Drug: Atezolizumab
- Drug: Doxorubicin
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous cell or adenocarcinoma of the cervix * At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting * Measurable disease * ECOG≤2 * Adequate pretreatment hematologic, renal and hepatic function test * Patients are allowed to have had bevacizumab during their prior treatment * Evidence of non-childbearing status for women of childbearing potential Exclusion Criteria: * History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years. * Previous anthracycline-based chemotherapy * Central nerve system metastases and leptomeningeal disease * Active or history of autoimmune disease * Prior allogenic bone marrow transplantation or prior solid organ transplantation * History of idiopathic pulmonary fibrosis * Known positive test for HIV, or active hepatitis B or hepatitis C * Known active tuberculosis * Severe infection within 4 weeks prior to initiation of study treatment * Prior immunotherapy
References
Publications (0)
Data not yet available