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

October 9, 2024 updated by: Immodulon Therapeutics Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • France
      • Lyon, France, 69373
        • Centre Léon Bérard, Dpt Medecine & INSERM
      • Villejuif, France, 94805
        • Gustave Roussy Cancer Center
  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • St George's University of London, Institute of Infection and Immunity
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital Foundation Trust

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Nab-paclitaxel
Standard of Care chemotherapy
Other Names:
  • Abraxane
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 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Folinic Acid
Standard of Care chemotherapy
Other Names:
  • Leucovorin
Drug: Fluorouracil
Standard of Care chemotherapy
Other Names:
  • 5FU
Drug: Irinotecan
Standard of Care chemotherapy
Other Names:
  • Campto
  • Camptosar
Drug: Oxaliplatin
Standard of Care chemotherapy
Other Names:
  • Eloxatin
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 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
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 doses. This is followed by a dose every 4 weeks thereafter
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Nab-paclitaxel
Standard of Care chemotherapy
Other Names:
  • Abraxane
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 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
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 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
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 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Nab-paclitaxel
Standard of Care chemotherapy
Other Names:
  • Abraxane
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 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
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 one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Cyclophosphamide
Standard of Care chemotherapy
Other Names:
  • cytophosphane
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 the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Gemcitabine
Standard of Care chemotherapy
Other Names:
  • GEMZAR
Drug: Capecitabine
Standard of Care chemotherapy
Other Names:
  • Xeloda
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 dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Folinic Acid
Standard of Care chemotherapy
Other Names:
  • Leucovorin
Drug: Fluorouracil
Standard of Care chemotherapy
Other Names:
  • 5FU
Drug: Oxaliplatin
Standard of Care chemotherapy
Other Names:
  • Eloxatin
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 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.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Drug: Folinic Acid
Standard of Care chemotherapy
Other Names:
  • Leucovorin
Drug: Fluorouracil
Standard of Care chemotherapy
Other Names:
  • 5FU
Drug: Irinotecan
Standard of Care chemotherapy
Other Names:
  • Campto
  • Camptosar
Biological: cetuximab
Standard of Care immunotherapy
Other Names:
  • Erbitux
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 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.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Biological: Anti-PD1
Standard of Care immunotherapy
Other Names:
  • pembrolizumab (KEYTRUDA),
  • nivolumab (OPDIVO)
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 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.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Biological: Anti-PD1
Standard of Care immunotherapy
Other Names:
  • pembrolizumab (KEYTRUDA),
  • nivolumab (OPDIVO)
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 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.
Biological: IMM-101
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
Other Names:
  • Heat killed M. obuense (NCTC 13365)
Biological: Ipilimumab
Standard of Care immunotherapy
Other Names:
  • YERVOY

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Week 28 through study completion (maximum 4.5 years)
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
Time Frame: From screening until study termination an average of 3 months.
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
Time Frame: 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

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)
Time Frame: 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.
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.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immodulon Therapeutics Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Cunningham, MD FRCP, Royal Marsden Hospital Foundation Trust

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMM-101-011
  • 2016 001459 28 (EudraCT Number)
  • CANC 32085 (Other Identifier: National Institute for Health Research (UK))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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