NCT03598270|CompletedPhase 3DMC

Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

ANITA

A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months

Grupo Español de Investigación en Cáncer de Ovario ClinicalTrials.gov

Compare

4 other identifiers

ENGOT-Ov41/GEICO 69-O/ANITA2018-000366-11ENGOT-Ov41GEICO 69-O

Study Type

interventional

Target

417

Locations

5 countries

Sites

Timeline

RegisteredJul 2018

StartedNov 2018

CompletionAug 2024

Brief Summary

Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after \>100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision. Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles. Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination. The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

417

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2018

Longer than P75 for phase_3

Geographic Reach

5 countries

71 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

First Submitted

Initial submission to the registry

June 2, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed

4 months until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2024

Completed

Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

5.7 years

First QC Date

June 2, 2018

Last Update Submit

August 28, 2024

Conditions

Recurrent Ovarian Carcinoma

Keywords

OvarianAtezolizumabNiraparib

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)
Period from study entry (day of randomization) until disease progression, death or date of last contact. Progression will be based on tumor assessment made by the investigators according to the RECIST v1.1 criteria.
30 months

Secondary Outcomes (21)

Overall survival (OS)
60 months
Time to first subsequent therapy or death (TFST)
60 months
Time to second subsequent therapy or death (TSST)
60 months
Time to second progression or death (PFS2)
60 months
Incidence of Treatment Adverse Events
60 months
+16 more secondary outcomes

Other Outcomes (14)

Evaluate PROs of disease associated with atezolizumab versus placebo
60 months
Evaluate PROs of disease associated with atezolizumab versus placebo
60 months
Evaluate treatment-related symptoms associated with atezolizumab versus placebo
60 months
+11 more other outcomes

Study Arms (2)

Arm A (Control Arm)

PLACEBO COMPARATOR

Placebo of atezolizumab in combination with one of the platinum based regimens below (investigator's choice) followed by maintenance niraparib with placebo: * Carboplatin (AUC = 5, d1) plus paclitaxel and placebo every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with placebo every 3 weeks * Carboplatin (AUC = 4, d1) plus gemcitabine and placebo every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with placebo every 3 weeks. * Carboplatin (AUC = 5, d1) plus pegylated liposomal doxorubicin (PLD) and placebo every 4 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with placebo every 3 weeks.

Drug: PlaceboDrug: CarboplatinDrug: PaclitaxelDrug: NiraparibDrug: GemcitabineDrug: Pegylated liposomal doxorubicin (PLD)

Arm B (experimental arm)

EXPERIMENTAL

Atezolizumab in combination with one of the platinum based regimens below (investigator's choice) followed by maintenance niraparib with atezolizumab: * Carboplatin (AUC = 5, d1) plus paclitaxel and atezolizumab every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with atezolizumab every 3 weeks. * Carboplatin (AUC = 4, d1) plus gemcitabine and atezolizumab every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with atezolizumab every 3 weeks. * Carboplatin (AUC = 5, d1) plus pegylated liposomal doxorubicin (PLD) and atezolizumab every 4 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with atezolizumab every 3 weeks.

Drug: CarboplatinDrug: PaclitaxelDrug: NiraparibDrug: GemcitabineDrug: Pegylated liposomal doxorubicin (PLD)Drug: Atezolizumab

Interventions

PlaceboDRUG

Volume equivalent to 1200 mg of atezolizumab drug product. Intravenous Day 1

Also known as: Placebo of Atezolizumab

Arm A (Control Arm)

CarboplatinDRUG

Intravenous. Day 1