Study Stopped
Commercial reasons
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
MODULATE
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
3 other identifiers
interventional
2
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2017
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedStudy Start
First participant enrolled
May 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedResults Posted
Study results publicly available
November 25, 2024
CompletedNovember 25, 2024
October 1, 2024
3 months
December 16, 2016
March 31, 2023
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
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
From screening until study termination an average of 3 months.
Response to Treatment
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)
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.
Study Arms (17)
IMM-101 + Gem panc ca
EXPERIMENTALIMM-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 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+Gem/nab-paclitaxel panc ca
EXPERIMENTALIMM-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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+Gem+capecitabine panc ca
EXPERIMENTALIMM-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 the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101 + FOLFIRINOX panc ca
EXPERIMENTALIMM-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 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+FOLFOX colorectal cancer (CRC)
EXPERIMENTALIMM-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 dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)
EXPERIMENTALIMM-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 period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+Gem cholangio
EXPERIMENTALIMM-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 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+Gem lung ca
EXPERIMENTALIMM-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 doses. This is followed by a dose every 4 weeks thereafter
IMM-101+Gem + nab-paclitaxel lung ca
EXPERIMENTALIMM-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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+ anti-programmed death-1 (PD1) lung ca
EXPERIMENTALIMM-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 nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen.
IMM-101+Gem melanoma
EXPERIMENTALIMM-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 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+ anti-programmed death-1 (PD1) melanoma
EXPERIMENTALIMM-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 the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.
IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma
EXPERIMENTALIMM-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 dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.
IMM-101+Gem breast cancer
EXPERIMENTALIMM-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 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+Gem/ nab-paclitaxel breast
EXPERIMENTALIMM-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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101 + Gem sarcoma
EXPERIMENTALIMM-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 doses. This is followed by a dose every 4 weeks thereafter.
IMM-101+cyclophosphamide
EXPERIMENTALIMM-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 one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Interventions
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care chemotherapy
Standard of Care immunotherapy
Standard of Care immunotherapy
Standard of Care immunotherapy
Standard of Care chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre LĂ©on BĂ©rard, Dpt Medecine & INSERM
Lyon, 69373, France
Gustave Roussy Cancer Center
Villejuif, 94805, France
St George's University of London, Institute of Infection and Immunity
London, SW17 0RE, United Kingdom
Royal Marsden Hospital Foundation Trust
London, SW3 6JJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only two patients were enrolled into the study before the study was terminated early by the Sponsor for commercial reasons. There were no specific safety concerns based on the data from the two patients treated. These limited data provide some preliminary indication regarding the safety and tolerability of IMM-101 when administered in combination with nivolumab. No meaningful assessment of efficacy could be made given that only two patients were enrolled into the study.
Results Point of Contact
- Title
- Chief Medical Odfficer
- Organization
- Immodulon Therapeutics Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
David Cunningham, MD FRCP
Royal Marsden Hospital Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2016
First Posted
January 4, 2017
Study Start
May 31, 2017
Primary Completion
August 30, 2017
Study Completion
August 30, 2017
Last Updated
November 25, 2024
Results First Posted
November 25, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share