Clinical trial NCT03009058: Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
Official title: A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Metastatic Cancer
Keywords: Unresectable cancer
pancreatic
melanoma
breast
lung
colorectal
cholangio
sarcoma
Lead sponsor: Immodulon Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type.

The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.

Detailed description: The study will consist of three phases - Screening, Treatment and Maintenance. Patients who provide informed consent, will participate in a Screening period of up to 28 days to establish eligibility. Once eligibility is confirmed, patients will enter the Treatment Phase of the study.

In the Treatment Phase all patients will receive IMM-101 for 28 weeks.

At Week 32, if the Investigator considers it in the patients' best interest patients will progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks (or as close to this interval as permitted due to practical or logistical considerations). Patients will be followed up for assessment of safety, response to treatment, survival, and immunological markers for up to 4.5 years.

Eligibility criteria: Inclusion Criteria:

* Metastatic or unresectable cancer and considered by their physician to be indicated for a new line of SOC as listed in the protocol
* Are ineligible for a disease specific clinical study with IMM-101
* Have an estimated life expectancy greater than 3 months (from Day 0)
* Give signed informed consent for participation in the study
* Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤2 at Day 0.
* Have adequate bone marrow, hepatic and renal function

Exclusion Criteria:

* Patient has previously received treatment with IMM-101
* Patient is currently part way through a course of chemotherapy or immunotherapy
* Patient is receiving concomitant treatment with another investigational product
* Patient has received an investigational drug within the 4 weeks prior to IMM 101 administration
* Patient has significant cardiovascular disease
* Patient has any previous or concurrent malignancy (excluding adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence)
* Patient has co existing active infection or medical condition which will substantially increase the risk associated with the patient's participation in the study
* Patient has uncontrolled hypercalcaemia
* Patient has previously experienced an allergic reaction to any mycobacterial product.
* The patient has a history of non-infectious pneumonitis that required steroids or current pneumonitis
* Patient has received live vaccine within 30 days of planned start of study medication
* Patient is pregnant or a breast feeding woman.
* Patient is unwilling to use a medically acceptable, effective method of contraception throughout the treatment period and for at least 6 months after discontinuation of treatment.
* Patient has used depot corticosteroids in the 6 weeks before initiation of Screening
* Patient has had chronic use of systemic corticosteroids within the 2 week period before the first administration of IMM-101
* Patient has received a blood transfusion within 4 weeks prior to Screening
* In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol.

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.
Secondary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Week 28 through study completion (maximum 4.5 years)
measure: Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor
timeFrame: From screening until study termination an average of 3 months.
measure: Response to Treatment
timeFrame: Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients
measure: Overall Survival (OS)
timeFrame: From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard, Dpt Medecine & INSERM
city: Villejuif
country: France
facility: Gustave Roussy Cancer Center
city: London
country: United Kingdom
facility: St George's University of London, Institute of Infection and Immunity
city: London
country: United Kingdom
facility: Royal Marsden Hospital Foundation Trust
Study officials:
affiliation: Royal Marsden Hospital Foundation Trust
name: David Cunningham, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: