CHARIOT : Phase II Single Arm Study evaluating safety, feasibility and efficacy of Ipilimumab and Nivolumab with neoadjuvant weekly Paclitaxel after Anthracycline based chemotherapy in High-risk primary Triple Negative Breast Cancer, followed by definite surgery and completion of 1 year total duration of Nivolumab

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Multiple treatment types | BreastBreast

Trial Overview Read MoreRead more

This phase II trial is evaluating two immunotherapy drugs (Ipilimumab and Nivolumab) in combination with a weekly chemotherapy drug (Paclitaxel) for the treatment of Triple Negative Breast Cancer, followed by surgery and further Nivolumab treatment.
 

This trial is treating patients with Triple Negative Breast Cancer.

This is a systemic therapy and surgical 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 not 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

Phase II Single Arm Study evaluating safety, feasibility and efficacy of Ipilimumab and Nivolumab with neoadjuvant weekly Paclitaxel after Anthracycline based chemotherapy in High-risk primary Triple Negative Breast Cancer, followed by definite surgery and completion of 1 year total duration of Nivolumab

Cooperative Group

Australian New Zealand Breast Cancer Trials Group (ANZBCTG)

Summary

Before surgery, patients will receive the following treatments, simultaneously, over a 12 week period - Intravenous Nivolumab at 3mg/kg every 2 weeks for 6 doses; Intravenous Ipilimumab at 1mg/kg every 6 weeks for 2 doses; and Intravenous Paclitaxel at 80mg/m^2 for 12 doses. Where administration of the study drugs occur on the same day, Nivolumab is given first, Ipilimumab second and Paclitaxel last. Surgery will take place within 4 weeks of the last paclitaxel dose. Participants will recommence Nivolumab 2-6 weeks after surgery as determined by the investigator.

Recruiting Hospitals Read MoreRead more

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

Not Recruiting Hospitals Read MoreRead more

Not currently recruiting

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

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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