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Trial Status

In Follow-up

Cancer Type

Colorectal Cancer

Protocol Title

Modulation of the tumour microenvironment using either vascular disrupting agents or STAT3 inhibition in order to synergise with PD1 inhibition in microsatellite stable, refractory colorectal cancer.

Purpose of the Study

This Phase II research project will test the efficacy, safety, and tolerability of an experimental drug combination: either nivolumab and BBI608 or nivolumab and BNC105 in patients with metastatic colorectal cancer who have previously failed standard of care treatment.

Eligibility Criteria

Inclusion Criteria

  1. Patient has a histological diagnosis of adenocarcinoma of colorectal origin.
  2. Metastatic disease that is not resectable.
  3. Male or female patients > 18 years of age at screening.
  4. Life expectancy of at least 12 weeks
  5. No other concurrent uncontrolled medical conditions
  6. No other malignant disease apart from non‐melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse.
  7. Female patients of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to randomisation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  8. Patient has provided written informed consent

Exclusion Criteria

  1. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol.
  2. Patients with any active, known, or suspected autoimmune disease.
  3. Patient has evidence of interstitial lung disease or active, non‐infectious pneumonitis.
  4. Has an active infection requiring systemic therapy.
  5. Patients receiving long‐term anti‐coagulation or anti‐platelet agents which cannot be ceased for an appropriate interval to allow mandatory tumour biopsies prior to and during therapy.
  6. Has a known history of HIV (HIV 1/2 antibodies).
  7. Known active brain metastases
  8. Pregnancy

Contact Email

Maria.Farrell@petermac.org

PRINCIPAL INVESTIGATOR

Professor Niall Tebbutt

DETAILED INFORMATION AVAILABLE

More information available online at the ClinicalTrials.gov, Identifier: NCT03647839. Click here for more.

Funding

BMS Australia

Participating Centres

New South Wales
Westmead Hospital
Northern Cancer Institute
Newcastle Private Hospital
Border Medical Oncology
Queensland
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Ashford Cancer Centre
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Austin Health
Western Health-Sunshine Hospital
Monash Medical Centre
Ballarat Oncology & Haematology Services
Peninsula Health, Frankston Hospital
Box Hill Hospital/Eastern Health

Trial Status

In Follow-up

Cancer Type

Colorectal Cancer

Protocol Title

Modulation of the tumour microenvironment using either vascular disrupting agents or STAT3 inhibition in order to synergise with PD1 inhibition in microsatellite stable, refractory colorectal cancer

AIM

Primary Objective:

  • To determine the response rate (Immune RECIST)

Secondary Objective:

  • To determine treatment related toxicity
  • To determine progression free survival
  • To determine overall survival
  • Exploratory studies of biomarkers

BACKGROUND

Colorectal cancer is the most commonly diagnosed cancer in the Australian population. Surgery, with or without chemotherapy and radiotherapy, can be used to cure colorectal cancer that is diagnosed early. However, cases of advanced colorectal cancer where it has spread to other organs usually cannot be cured. Advanced colorectal cancer is treated with chemotherapy and other drugs, known as targeted therapies.  This can control advanced colorectal cancer for a limited time, but inevitably these cancers will evolve to become resistant to all the standard treatments available.  By the time cancers progress to this stage, survival is poor and patients are increasingly symptomatic.  Additional therapies are therefore needed to further extend survival of patients with advanced colorectal cancer.

CLINICAL TRIAL DESIGN

This study is a prospective randomised study that will recruit 90 patients with advanced MSS colorectal cancer at approximately 15 sites in Australia. The study will recruit patients with advanced colorectal cancer who have received and failed all standard treatments.  It is hoped that these approaches will benefit patients but this is unknown.  The approaches are highly experimental, but there is no placebo or control arm.

Arm 1:

  • Nivolumab (240mg every 14 days)
  • BNC105 (16mg/m2/day on day 1 and 8 every 21 days)

For 24 months or until disease progression or unacceptable toxicity.

Arm 2:

  • Nivolumab (240mg every 14 days)
  • BBI608 (240mg bd continuous)

For 24 months or until disease progression or unacceptable toxicity.

Patients Recruited

Click to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

New South Wales
Westmead Hospital
Northern Cancer Institute
Newcastle Private Hospital
Border Medical Oncology
Queensland
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Ashford Cancer Centre
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Austin Health
Western Health-Sunshine Hospital
Monash Medical Centre
Ballarat Oncology & Haematology Services
Peninsula Health, Frankston Hospital
Box Hill Hospital/Eastern Health

Principal Investigator

A/Professor Niall Tebbutt

Detailed Information

More information available online at the ClinicalTrials.gov, Identifier: NCT03647839. Click here for more.

Funding

Bristol-Myers Squibb