Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix
Brief Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: chemotherapy: Paclitaxel/Cisplatin | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: chemotherapy: Paclitaxel/Carboplatin | Intervention Type: DRUG; Name: chemotherapy: Paclitaxel/Cisplatin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: chemotherapy: Paclitaxel/Carboplatin; Assigned to Arm(s): 2
B: Arm Label: I; Type: EXPERIMENTAL; Interventions: Drug: Topotecan, Drug: Cisplatin, Drug: Bevacizumab | Intervention Type: DRUG; Name: Topotecan; Assigned to Arm(s): I | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): I | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): I
C: Arm Label: Arm A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bevacizumab, Drug: Cisplatin/Carboplatin, Drug: Paclitaxel | Arm Label: Arm B; Type: EXPERIMENTAL; Interventions: Drug: Atezolizumab, Drug: Bevacizumab, Drug: Cisplatin/Carboplatin, Drug: Paclitaxel | Intervention Type: DRUG; Name: Atezolizumab; Assigned to Arm(s): Arm B | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Arm A, Arm B | Intervention Type: DRUG; Name: Cisplatin/Carboplatin; Assigned to Arm(s): Arm A, Arm B | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm A, Arm B
D: Arm Label: Arm I (paclitaxel and cisplatin); Type: ACTIVE_COMPARATOR; Interventions: Drug: Cisplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration | Arm Label: Arm II (paclitaxel, cisplatin, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Cisplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration | Arm Label: Arm III (topotecan hydrochloride and paclitaxel); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Topotecan Hydrochloride | Arm Label: Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Topotecan Hydrochloride | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (paclitaxel, cisplatin, bevacizumab), Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab) | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Arm I (paclitaxel and cisplatin), Arm II (paclitaxel, cisplatin, bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (paclitaxel and cisplatin), Arm II (paclitaxel, cisplatin, bevacizumab), Arm III (topotecan hydrochloride and paclitaxel), Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (paclitaxel and cisplatin), Arm II (paclitaxel, cisplatin, bevacizumab), Arm III (topotecan hydrochloride and paclitaxel), Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (paclitaxel and cisplatin), Arm II (paclitaxel, cisplatin, bevacizumab), Arm III (topotecan hydrochloride and paclitaxel), Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab) | Intervention Type: OTHER; Name: Questionnaire Administration; Assigned to Arm(s): Arm I (paclitaxel and cisplatin), Arm II (paclitaxel, cisplatin, bevacizumab), Arm III (topotecan hydrochloride and paclitaxel), Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab) | Intervention Type: DRUG; Name: Topotecan Hydrochloride; Assigned to Arm(s): Arm III (topotecan hydrochloride and paclitaxel), Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)

Answer: C