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

Metastatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03009058
• Other study ID #: IMM-101-011
• Secondary ID: 2016 001459 28CA
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 24, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: Immodulon Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Biological:
• IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365

Drug:
• Gemcitabine
Standard of Care chemotherapy
• Nabpaclitaxel
Standard of Care chemotherapy
• Capecitabine
Standard of Care chemotherapy
• Folinic Acid
Standard of Care chemotherapy
• Fluorouracil
Standard of Care chemotherapy
• Irinotecan
Standard of Care chemotherapy
• Oxaliplatin
Standard of Care chemotherapy

Biological:
• cetuximab
Standard of Care immunotherapy
• Anti-PD1
Standard of Care immunotherapy
• Ipilimumab
Standard of Care immunotherapy

Drug:
• Cyclophosphamide
Standard of Care chemotherapy

Locations

Country	Name	City	State
France	Centre Léon Bérard, Dpt Medecine & INSERM	Lyon
France	Gustave Roussy Cancer Center	Villejuif
United Kingdom	Royal Marsden Hospital Foundation Trust	London
United Kingdom	St George's University of London, Institute of Infection and Immunity	London

Sponsors (1)

Lead Sponsor	Collaborator
Immodulon Therapeutics Ltd

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Initial assessment at Week 28
Secondary	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)
Secondary	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	Initial assessments at Week 12 and Week 28 then through study completion (maximum 4.5 years)
Secondary	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	Initial assessment at Week 28 then through study completion (maximum 4.5 years)
Secondary	Overall survival (OS)		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