Study on INBRX-106 and Pembrolizumab as a Chemotherapy-Free Treatment for Stage II Triple Negative Breast Cancer (TNBC)

Sponsor: Providence Health & Services

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06353997

Provider View

This clinical trial is exploring a new treatment option for patients with Stage II Triple Negative Breast Cancer (TNBC) that avoids the use of traditional chemotherapy. The study is testing the combination of two drugs, INBRX-106 and Pembrolizumab, to see if they can effectively treat TNBC before surgery.

Patient Parameters

Program Overview

The purpose of this Phase II study is to test if the combination of INBRX-106 and Pembrolizumab can be a feasible treatment option for patients with Stage II Triple Negative Breast Cancer (TNBC) without using chemotherapy. The study will evaluate the effects of this treatment on the cancer and compare different dosing schedules to see which works best.

Description

This study uses a two-stage design to minimize patient exposure if the treatment is not effective. If the initial results are promising, the study will expand to include more participants. The study aims to see if the treatment can achieve a complete response in a significant number of patients, which would encourage further research.

The study will stop if too many patients experience rapid disease progression or severe side effects. The treatment's effectiveness will be measured by the number of patients who achieve a complete response without chemotherapy. If no responses are observed, the study may consider a different approach using specific biomarkers.

Participants will be closely monitored for any side effects and the overall impact of the treatment on their cancer. The study aims to provide a new treatment option for patients with Stage II TNBC that avoids the side effects of traditional chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, any gender.
  • Have a good overall health status (ECOG score of 0 or 1).
  • Diagnosed with Triple Negative Breast Cancer (TNBC) with specific characteristics.
  • Primary breast tumor must be at least 2 cm and measurable by ultrasound.
  • No signs of cancer spreading to nearby lymph nodes.
  • Allowed to have multiple tumors if they are all TNBC.
  • No previous treatment for TNBC.
  • Willing to undergo regular ultrasounds, biopsies, and blood tests.
  • Must have adequate organ function based on specific blood tests.
  • Must agree to use effective birth control methods during and after the study if of childbearing potential.
  • Pre-menopausal women must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have cancer in both breasts.
  • Have other cancers that need ongoing treatment or are likely to return.
  • Have cancer that has spread to other parts of the body.
  • Have a primary tumor that is causing symptoms or likely to cause skin or muscle involvement.
  • Have had previous treatment with certain immune therapies.
  • Have allergies to the study drugs.
  • Have an immune deficiency or are on high-dose steroids or other immune-suppressing treatments.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have received a live vaccine recently.
  • Have a psychiatric or substance abuse disorder that would interfere with the study.
  • Are pregnant or breastfeeding.
  • Have a history of lung inflammation or organ transplant.
  • Have active infections or a history of certain viral infections like HIV or Hepatitis B/C.
  • Have a history of tuberculosis.

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