Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer.
Brief Summary: Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)

PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.

In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.

The question is:

Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.


Options:
A: Arm Label: Pazopanib/Paclitaxel association; Type: EXPERIMENTAL; Interventions: Drug: Pazopanib, Drug: Paclitaxel | Arm Label: Paclitaxel alone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paclitaxel | Intervention Type: DRUG; Name: Pazopanib; Assigned to Arm(s): Pazopanib/Paclitaxel association | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Paclitaxel alone, Pazopanib/Paclitaxel association
B: Arm Label: non platinum based chemotherapy; Type: EXPERIMENTAL; Interventions: Drug: stealth liposomal doxorubicin, Drug: carboplatin, Drug: paclitaxel, Drug: Topotecan, Drug: Gemcitabine | Arm Label: platinum based chemotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: stealth liposomal doxorubicin, Drug: carboplatin, Drug: paclitaxel, Drug: Topotecan, Drug: Gemcitabine | Intervention Type: DRUG; Name: stealth liposomal doxorubicin; Assigned to Arm(s): non platinum based chemotherapy, platinum based chemotherapy | Intervention Type: DRUG; Name: carboplatin; Assigned to Arm(s): non platinum based chemotherapy, platinum based chemotherapy | Intervention Type: DRUG; Name: paclitaxel; Assigned to Arm(s): non platinum based chemotherapy, platinum based chemotherapy | Intervention Type: DRUG; Name: Topotecan; Assigned to Arm(s): non platinum based chemotherapy, platinum based chemotherapy | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): non platinum based chemotherapy, platinum based chemotherapy
C: Arm Label: Arm I (paclitaxel, docetaxel, carboplatin); Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Docetaxel, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment | Arm Label: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Drug: Docetaxel, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment | Arm Label: Arm III (gemcitabine hydrochloride, carboplatin); Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Drug: Gemcitabine Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment | Arm Label: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Drug: Gemcitabine Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab) | Intervention Type: DRUG; Name: Gemcitabine Hydrochloride; Assigned to Arm(s): Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
D: Arm Label: Niraparib monotherapy; Type: EXPERIMENTAL; Interventions: Drug: Niraparib | Arm Label: Niraparib-bevacizumab combination; Type: EXPERIMENTAL; Interventions: Drug: Niraparib, Drug: Bevacizumab | Intervention Type: DRUG; Name: Niraparib; Assigned to Arm(s): Niraparib monotherapy, Niraparib-bevacizumab combination | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Niraparib-bevacizumab combination

Answer: D