Safety and efficacy of novel immunotherapy combinations in triple negative breast cancer - Clinical trial • Breast Cancer Foundation NZ

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Safety and efficacy of novel immunotherapy combinations in triple negative breast cancer

Advanced Breast Cancer clinical trials for Triple negative

Recruiting
Updated: July 6, 2020

This dose escalation and expansion study will investigate the use of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab in patients with advanced or metastatic triple negative breast cancer.

This study will investigate the use of tesetaxel in patients with taxane-naïve, HER2-, HR+ locally advanced or metastatic breast cancer.

Who is it for?

You may be eligible for this study if you meet the below criteria:

  • Patients with advanced/metastatic TNBC (defined as HER-2 negative with <1% of tumor cell nuclei immunoreactive for estrogen receptor (ER) and progesterone receptor (PR)), with measurable disease as determined by RECIST version 1.1. Tumor lesions previously irradiated or subjected to other loco-regional therapy will only be considered measurable if there is documented disease progression at the treated site prior to study entry.
  • Patients should have received standard chemotherapy for advanced or metastatic disease but should not have received more than two prior lines of chemotherapy. Neoadjuvant or adjuvant chemotherapy will count as one prior line.
  • Patients must have received prior systemic treatment that included taxane-based chemotherapy for neoadjuvant or metastatic disease.
  • Patients must have a site of disease amenable to core needle biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at screening, and during therapy on the study. Exceptions may be considered after documented discussion with Novartis. Patients with available archival tumor tissue obtained ≤6 months prior to study treatment initiation do not need to undergo a new tumor biopsy at screening, if the patient has not received any anti-cancer therapy since the biopsy was taken, and if adequate tissue is available.

Study details

This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC.

During the dose-escalation part of each treatment arm, patients will be treated with fixed doses of spartalizumab + LAG525 in combination with partner investigational drugs to be escalated until the MTD is reached or a lower RDE is established: NIR178, capmatinib, MCS110, or canakinumab. It is anticipated that other partner study drugs may be added in the future by protocol amendment.

After the determination of the MTD/RDE for a particular treatment arm, dose expansion may begin in that arm in order to further assess safety, tolerability, PK/PD, and anti-tumor activity of each combination at the MTD/RDE. Dose expansion arms may initiate only after consideration by the Investigators and Novartis of all available toxicity information, the assessment of risk to future patients from the BLRM, and the available PK, preliminary efficacy, and PD information. There is no requirement for dose-escalation treatment arms reaching an MTD/RDE to proceed to dose expansion.

Full trial information

Australia

Westmead, Sydney

Contact:

Novartis Pharmaceuticals

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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