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

Primary Purpose

Metastatic Cancer

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IMM-101
Gemcitabine
Nabpaclitaxel
Capecitabine
Folinic Acid
Fluorouracil
Irinotecan
Oxaliplatin
cetuximab
Anti-PD1
Ipilimumab
Cyclophosphamide
Sponsored by
Immodulon Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Unresectable cancer, pancreatic, melanoma, breast, lung, colorectal, cholangio, sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Léon Bérard, Dpt Medecine & INSERM
  • Gustave Roussy Cancer Center
  • St George's University of London, Institute of Infection and Immunity
  • Royal Marsden Hospital Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

IMM-101 + Gem panc ca

IMM-101+Gem/nab-paclitaxel panc ca

IMM-101+Gem+capecitabine panc ca

IMM-101 + FOLFIRINOX panc ca

IMM-101+FOLFOX colorectal cancer

IMM-101+FOLFIRI+CETUXIMAB CRC

IMM-101+Gem cholangio

IMM-101+Gem lung ca

IMM-101+Gem + nab-paclitaxel lung ca

IMM-101+anti-PD1 lung ca

IMM-101+Gem melanoma

IMM-101+anti-PD1 melanoma

IMM-101+ anti-CTLA-4 melanoma

IMM-101+Gem breast cancer

IMM-101+Gem/ nab-paclitaxel breast

IMM-101 + Gem sarcoma

IMM-101+cyclophosphamide

Arm Description

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 doses. This is followed by a dose every 4 weeks thereafter.

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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.

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 the next 3 doses. This is followed by a dose every 4 weeks thereafter.

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 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.

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 dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.

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 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 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 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 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 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 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 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 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 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 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 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
Overall survival (OS)

Full Information

First Posted
December 16, 2016
Last Updated
August 8, 2018
Sponsor
Immodulon Therapeutics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03009058
Brief Title
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
Acronym
MODULATE
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Commercial reasons
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immodulon Therapeutics Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Unresectable cancer, pancreatic, melanoma, breast, lung, colorectal, cholangio, sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMM-101 + Gem panc ca
Arm Type
Experimental
Arm Description
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 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+Gem/nab-paclitaxel panc ca
Arm Type
Experimental
Arm Description
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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+Gem+capecitabine panc ca
Arm Type
Experimental
Arm Description
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 the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101 + FOLFIRINOX panc ca
Arm Type
Experimental
Arm Description
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 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+FOLFOX colorectal cancer
Arm Type
Experimental
Arm Description
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 dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+FOLFIRI+CETUXIMAB CRC
Arm Type
Experimental
Arm Description
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 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.
Arm Title
IMM-101+Gem cholangio
Arm Type
Experimental
Arm Description
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 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+Gem lung ca
Arm Type
Experimental
Arm Description
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 doses. This is followed by a dose every 4 weeks thereafter
Arm Title
IMM-101+Gem + nab-paclitaxel lung ca
Arm Type
Experimental
Arm Description
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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+anti-PD1 lung ca
Arm Type
Experimental
Arm Description
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 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.
Arm Title
IMM-101+Gem melanoma
Arm Type
Experimental
Arm Description
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 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+anti-PD1 melanoma
Arm Type
Experimental
Arm Description
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 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.
Arm Title
IMM-101+ anti-CTLA-4 melanoma
Arm Type
Experimental
Arm Description
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 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.
Arm Title
IMM-101+Gem breast cancer
Arm Type
Experimental
Arm Description
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 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+Gem/ nab-paclitaxel breast
Arm Type
Experimental
Arm Description
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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101 + Gem sarcoma
Arm Type
Experimental
Arm Description
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 doses. This is followed by a dose every 4 weeks thereafter.
Arm Title
IMM-101+cyclophosphamide
Arm Type
Experimental
Arm Description
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 one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Intervention Type
Biological
Intervention Name(s)
IMM-101
Other Intervention Name(s)
Heat killed M. obuense (NCTC) 13365)
Intervention Description
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
GEMZAR
Intervention Description
Standard of Care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Nabpaclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
Standard of Care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Standard of Care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Folinic Acid
Other Intervention Name(s)
Leucovorin
Intervention Description
Standard of Care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5FU
Intervention Description
Standard of Care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Campto, Camptosar
Intervention Description
Standard of Care chemotherapy
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Standard of Care chemotherapy
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Standard of Care immunotherapy
Intervention Type
Biological
Intervention Name(s)
Anti-PD1
Other Intervention Name(s)
pembrolizumab (KEYTRUDA),, nivolumab (OPDIVO)
Intervention Description
Standard of Care immunotherapy
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
YERVOY
Intervention Description
Standard of Care immunotherapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
cytophosphane
Intervention Description
Standard of Care chemotherapy
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
Time Frame
Initial assessment at Week 28
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
Time Frame
Week 28 through study completion (maximum 4.5 years)
Title
Number of participants with treatment-related adverse events when IMM-101 is given in combination with a checkpoint blockade inhibitor
Description
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
Time Frame
Initial assessments at Week 12 and Week 28 then through study completion (maximum 4.5 years)
Title
Response to treatment
Description
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
Time Frame
Initial assessment at Week 28 then through study completion (maximum 4.5 years)
Title
Overall survival (OS)
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cunningham, MD FRCP
Organizational Affiliation
Royal Marsden Hospital Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard, Dpt Medecine & INSERM
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Gustave Roussy Cancer Center
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
St George's University of London, Institute of Infection and Immunity
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Royal Marsden Hospital Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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