iPRIME : A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Systemic therapy | Female reproductive organsFallopian tube,Ovary,Peritoneal

Trial Overview Read MoreRead more

This phase II trial is trying to determine how effective it is to combine two targeted cancer drugs (durvalumab and tremelimumab) with standard chemotherapy treatment in patients with ovarian, fallopian tube or peritoneal cancers.
 

This trial is treating patients with ovarian, fallopian tube or peritoneal cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers

Cooperative Group

Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Summary

Participants will be randomised in the ratio of 2:1 between the Arms: Arm 1: Carboplatin, paclitaxel combined with durvalumab and tremelimumab (Du-T-NACT), followed by maintenance durvalumab and tremelimumab a) Carboplatin: AUC 5 via intravenous infusion on Day 1 of each 21 day cycle, for a total of 18 weeks b) Paclitaxel: 175 mg/m2 via intravenous infusion on Day 1 of each 21 day cycle, for a total of 18 weeks c) Durvalumab: 1500mg via intravenous infusion on Day 1 of each 21 day cycle, for a total of 36 weeks d) Tremelimumab: 75mg via intravenous infusion on Day 1 of each 21 day cycle, for a total of 36 weeks Following completion of 3 cycles of neoadjuvant treatment, patients in both arms who are suitable for interval debulking surgery (IDS) should undergo debulking surgery with the goal of optimal cytoreduction by a certified gynaecological oncologist. Surgery should be performed at least 21 days after cycle 3 day 1 (C3D22) but before day 36 (C3D36) provided adequate haematological and clinical recovery. Patients in Arm 1 who continue to respond will receive maintenance therapy with durvalumab and tremelimumab. Maintenance treatment should commence 4 weeks ± 3 days following the last dose of adjuvant treatment in cycle 6 and continue for 36 weeks or until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Maintenance immunotherapy will consist of: a) Durvalumab: 1500mg via intravenous infusion on Day 1 of each 21 day cycle, for a total of 36 weeks b) Tremelimumab: 75mg via intravenous infusion on Day 1 of each 21 day cycle, for a total of 36 weeks

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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