Study Of IMM 101 In Combination With Standard Of Care In Patients With Metastatic Or Unresectable Cancer

Study Overview

Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer

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.

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.

Metastatic Cancer

BIOLOGICAL: IMM-101
DRUG: Gemcitabine
DRUG: Nab-paclitaxel
DRUG: Capecitabine
DRUG: Folinic Acid
DRUG: Fluorouracil
DRUG: Irinotecan
DRUG: Oxaliplatin
BIOLOGICAL: cetuximab
BIOLOGICAL: Anti-PD1
BIOLOGICAL: Ipilimumab
DRUG: Cyclophosphamide

IMM-101-011
2016 001459 28 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )
CANC 32085 (OTHER Identifier) (OTHER: National Institute for Health Research (UK))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-12-16	Results First Submitted 2023-03-31	Last Update Submitted that met QC Criteria 2024-10-09
First Submitted that Met QC Criteria 2016-12-30	Results First Submitted that Met QC Criteria 2024-10-09	Last Update Posted (ACTUAL) 2024-11-25
First Posted (ACTUAL) 2017-01-04	Results First Posted 2024-11-25	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: IMM-101 + Gem panc ca IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 dose	BIOLOGICAL: IMM-101 A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 DRUG: Gemcitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+Gem/nab-paclitaxel panc ca IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2	DRUG: Nab-paclitaxel Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+Gem+capecitabine panc ca IMM-101 will be given in combination with gemcitabine + capecitabine combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for	DRUG: Gemcitabine Standard of Care chemotherapy DRUG: Capecitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101 + FOLFIRINOX panc ca IMM-101 will be given in combination with standard FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan and OXaliplatin) treatment. The treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4	BIOLOGICAL: IMM-101 A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 DRUG: Folinic Acid Standard of Care chemotherapy DRUG: Fluorouracil Standard of Care chemotherapy DRUG: Irinotecan Standard of Care chemotherapy DRUG: Oxaliplatin Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+FOLFOX colorectal cancer (CRC) IMM-101 will be given in combination with standard FOLFOX (FOLinic acid, Fluorouracil and OXaliplatin) treatment. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one	DRUG: Folinic Acid Standard of Care chemotherapy DRUG: Fluorouracil Standard of Care chemotherapy DRUG: Oxaliplatin Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC) IMM-101 will be given in combination with standard FOLFIRI (FOLinic acid, Fluorouracil and IRInotecan) + cetuximab combination treatment. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest per	DRUG: Folinic Acid Standard of Care chemotherapy DRUG: Fluorouracil Standard of Care chemotherapy DRUG: Irinotecan Standard of Care chemotherapy BIOLOGICAL: cetuximab Standard of Care immunotherapy
EXPERIMENTAL: IMM-101+Gem cholangio IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 dose	DRUG: Gemcitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+Gem lung ca IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 dose	DRUG: Gemcitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+Gem + nab-paclitaxel lung ca IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2	DRUG: Gemcitabine Standard of Care chemotherapy DRUG: Nab-paclitaxel Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+ anti-programmed death-1 (PD1) lung ca IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the anti-PD1 (pembrolizumab or nivoluma	BIOLOGICAL: IMM-101 A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 BIOLOGICAL: Anti-PD1 Standard of Care immunotherapy
EXPERIMENTAL: IMM-101+Gem melanoma IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 dose	DRUG: Gemcitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+ anti-programmed death-1 (PD1) melanoma IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. The first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In t	BIOLOGICAL: IMM-101 A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 BIOLOGICAL: Anti-PD1 Standard of Care immunotherapy
EXPERIMENTAL: IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma IMM-101 will be given in combination with standard treatment with ipilimumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the ipilimumab cohort will receive IMM-101 at an increased dosi	BIOLOGICAL: IMM-101 A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 BIOLOGICAL: Ipilimumab Standard of Care immunotherapy
EXPERIMENTAL: IMM-101+Gem breast cancer IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 dose	DRUG: Gemcitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+Gem/ nab-paclitaxel breast IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2	DRUG: Gemcitabine Standard of Care chemotherapy DRUG: Nab-paclitaxel Standard of Care chemotherapy
EXPERIMENTAL: IMM-101 + Gem sarcoma IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 dose	BIOLOGICAL: IMM-101 A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 DRUG: Gemcitabine Standard of Care chemotherapy
EXPERIMENTAL: IMM-101+cyclophosphamide IMM-101 will be given in combination with low dose cyclophosphamide (300mg/m2 in patients with solid malignancies. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then on	DRUG: Cyclophosphamide Standard of Care chemotherapy

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions.	Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.

Secondary Outcome Measures	Measure Description	Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.	Week 28 through study completion (maximum 4.5 years)
Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor	Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents	From screening until study termination an average of 3 months.
Response to Treatment	Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator: * Immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions * Immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC * Immune-related Progressive Disease (irPD) is ≥25% increase in tumour burden from the lowest level recorded. * Everything else is considered immune-related Stable Disease (irSD).	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
Overall Survival (OS)	Assessment of overall survival (defined as the time from enrolment to death due to any cause).	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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: David Cunningham, MD FRCP, Royal Marsden Hospital Foundation Trust

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record