Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

ARTISTRY-7 : A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

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 III study is evaluating the effectiveness of combination immunotherapy (nemvaleukin + pembrolizumab), single agent immunotherapy (nemvaleukin or pembrolizumab), and chemotherapy (PLD, paclitaxel, topotecan or gemcitabine) in people with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
 

This trial is treating patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

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.

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 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Commercial Sponsor

Alkermes, Inc.

Summary

Eligible participants will be randomly allocated to one of four research arms. In Arm 1 (Experimental), participants will receive nemvaleukin (6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes) plus pembrolizumab (200mg; Day 1 of 21-day cycles; IV infusion over 30 minutes). In Arm 2 (Experimental), participants will receive pembrolizumab alone (200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes). In Arm 3 (Experimental), participants will receive nemvaleukin alone (6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes). In Arm 4 (Active Comparator), participants will receive the Investigator's choice of chemotherapy, either: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabin. The Investigator will pre-select the Investigator's choice treatment before the randomization of each participant. PLD will be administered at 40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+). Paclitaxel will be administered at 80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min. Topotecan will be administered at 4 mg/m2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min. Gemcitabine will be administered at 1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.

Recruiting Hospitals Read MoreRead more

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Jenni Flynn
jenni.flynn@epworth.org.au
03 9936 8206

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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