Metastatic CancerPhase 1/2MODULATENCT03009058
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
A Phase 1/2 study testing IMM-101, Gemcitabine and Nab-paclitaxel in people with Metastatic Cancer, run by Immodulon Therapeutics Ltd at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- IMM-101, Gemcitabine and Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 May 2017to 30 Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France2 sites
Centre Léon Bérard, Dpt Medecine & INSERM
Lyon, 69373
Gustave Roussy Cancer Center
Villejuif, 94805
United Kingdom2 sites
St George's University of London, Institute of Infection and Immunity
London, SW17 0RE
Royal Marsden Hospital Foundation Trust
London, SW3 6JJ
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- IMM-101, Gemcitabine, Nab-paclitaxel, Capecitabine, Folinic Acid
- Keywords
- Unresectable cancer, pancreatic, melanoma, breast, lung, colorectal, cholangio, sarcoma
- Medical subject headings
- Neoplasm Metastasis, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-101Biological
Also called Heat killed M. obuense (NCTC 13365)
A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
GemcitabineDrug
Also called GEMZAR
Standard of Care chemotherapy
Nab-paclitaxelDrug
Also called Abraxane
Standard of Care chemotherapy
CapecitabineDrug
Also called Xeloda
Standard of Care chemotherapy
Folinic AcidDrug
Also called Leucovorin
Standard of Care chemotherapy
FluorouracilDrug
Also called 5FU
Standard of Care chemotherapy
IrinotecanDrug
Also called Campto, Camptosar
Standard of Care chemotherapy
OxaliplatinDrug
Also called Eloxatin
Standard of Care chemotherapy
cetuximabBiological
Also called Erbitux
Standard of Care immunotherapy
Anti-PD1Biological
Also called pembrolizumab (KEYTRUDA),, nivolumab (OPDIVO)
Standard of Care immunotherapy
IpilimumabBiological
Also called YERVOY
Standard of Care immunotherapy
CyclophosphamideDrug
Also called cytophosphane
Standard of Care chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| IMM-101 + Gem panc ca | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine |
| IMM-101+Gem/nab-paclitaxel panc ca | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| IMM-101+Gem+capecitabine panc ca | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine; Drug: Capecitabine |
| IMM-101 + FOLFIRINOX panc ca | Experimental | 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. Receives: Biological: IMM-101; Drug: Folinic Acid; Drug: Fluorouracil; Drug: Irinotecan; Drug: Oxaliplatin |
| IMM-101+FOLFOX colorectal cancer (CRC) | Experimental | 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. Receives: Biological: IMM-101; Drug: Folinic Acid; Drug: Fluorouracil; Drug: Oxaliplatin |
| IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC) | Experimental | 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. Receives: Biological: IMM-101; Drug: Folinic Acid; Drug: Fluorouracil; Drug: Irinotecan; Biological: cetuximab |
| IMM-101+Gem cholangio | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine |
| IMM-101+Gem lung ca | Experimental | 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 Receives: Biological: IMM-101; Drug: Gemcitabine |
| IMM-101+Gem + nab-paclitaxel lung ca | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| IMM-101+ anti-programmed death-1 (PD1) lung ca | Experimental | 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. Receives: Biological: IMM-101; Biological: Anti-PD1 |
| IMM-101+Gem melanoma | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine |
| IMM-101+ anti-programmed death-1 (PD1) melanoma | Experimental | 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. Receives: Biological: IMM-101; Biological: Anti-PD1 |
| IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma | Experimental | 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. Receives: Biological: IMM-101; Biological: Ipilimumab |
| IMM-101+Gem breast cancer | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine |
| IMM-101+Gem/ nab-paclitaxel breast | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| IMM-101 + Gem sarcoma | Experimental | 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. Receives: Biological: IMM-101; Drug: Gemcitabine |
| IMM-101+cyclophosphamide | Experimental | 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. Receives: Biological: IMM-101; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start31 May 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Commercial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immodulon Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cunningham, MD FRCP, Principal investigator, Royal Marsden Hospital Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009058
- Sponsor's protocol ID
- IMM-101-011
- Other IDs
- 2016 001459 28, CANC 32085, 2016
- Acronym
- MODULATE
- Status last verified
- Oct 2024
- First submitted
- 16 Dec 2016
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03009058
- Acronym / sponsor ID
- MODULATE / IMM-101-011
- Conditions
- Metastatic Cancer
- Keywords
- Unresectable cancer, pancreatic, melanoma, breast, lung, colorectal, cholangio, sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Commercial reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Immodulon Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| IMM-101 + Gem panc ca | Experimental | Biological: IMM-101, Drug: GemcitabineIMM-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 | Experimental | Biological: IMM-101, Drug: Gemcitabine, Drug: Nab-paclitaxelIMM-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 | Experimental | Biological: IMM-101, Drug: Gemcitabine, Drug: CapecitabineIMM-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 | Experimental | Biological: IMM-101, Drug: Folinic Acid, Drug: Fluorouracil, Drug: Irinotecan, Drug: OxaliplatinIMM-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) | Experimental | Biological: IMM-101, Drug: Folinic Acid, Drug: Fluorouracil, Drug: OxaliplatinIMM-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) | Experimental | Biological: IMM-101, Drug: Folinic Acid, Drug: Fluorouracil, Drug: Irinotecan, Biological: cetuximabIMM-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 | Experimental | Biological: IMM-101, Drug: GemcitabineIMM-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 | Experimental | Biological: IMM-101, Drug: GemcitabineIMM-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 | Experimental | Biological: IMM-101, Drug: Gemcitabine, Drug: Nab-paclitaxelIMM-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 | Experimental | Biological: IMM-101, Biological: Anti-PD1IMM-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 | Experimental | Biological: IMM-101, Drug: GemcitabineIMM-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 | Experimental | Biological: IMM-101, Biological: Anti-PD1IMM-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 | Experimental | Biological: IMM-101, Biological: IpilimumabIMM-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 | Experimental | Biological: IMM-101, Drug: GemcitabineIMM-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 | Experimental | Biological: IMM-101, Drug: Gemcitabine, Drug: Nab-paclitaxelIMM-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 | Experimental | Biological: IMM-101, Drug: GemcitabineIMM-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 | Experimental | Biological: IMM-101, Drug: CyclophosphamideIMM-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM-101Also: Heat killed M. obuense (NCTC 13365)A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 | Biological | IMM-101 + FOLFIRINOX panc ca, IMM-101 + Gem panc ca, IMM-101 + Gem sarcoma, IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma, IMM-101+ anti-programmed death-1 (PD1) lung ca, IMM-101+ anti-programmed death-1 (PD1) melanoma, IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC), IMM-101+FOLFOX colorectal cancer (CRC), IMM-101+Gem + nab-paclitaxel lung ca, IMM-101+Gem breast cancer, IMM-101+Gem cholangio, IMM-101+Gem lung ca, IMM-101+Gem melanoma, IMM-101+Gem+capecitabine panc ca, IMM-101+Gem/ nab-paclitaxel breast, IMM-101+Gem/nab-paclitaxel panc ca, IMM-101+cyclophosphamide |
| GemcitabineAlso: GEMZARStandard of Care chemotherapy | Drug | IMM-101 + Gem panc ca, IMM-101 + Gem sarcoma, IMM-101+Gem + nab-paclitaxel lung ca, IMM-101+Gem breast cancer, IMM-101+Gem cholangio, IMM-101+Gem lung ca, IMM-101+Gem melanoma, IMM-101+Gem+capecitabine panc ca, IMM-101+Gem/ nab-paclitaxel breast, IMM-101+Gem/nab-paclitaxel panc ca |
| Nab-paclitaxelAlso: AbraxaneStandard of Care chemotherapy | Drug | IMM-101+Gem + nab-paclitaxel lung ca, IMM-101+Gem/ nab-paclitaxel breast, IMM-101+Gem/nab-paclitaxel panc ca |
| CapecitabineAlso: XelodaStandard of Care chemotherapy | Drug | IMM-101+Gem+capecitabine panc ca |
| Folinic AcidAlso: LeucovorinStandard of Care chemotherapy | Drug | IMM-101 + FOLFIRINOX panc ca, IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC), IMM-101+FOLFOX colorectal cancer (CRC) |
| FluorouracilAlso: 5FUStandard of Care chemotherapy | Drug | IMM-101 + FOLFIRINOX panc ca, IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC), IMM-101+FOLFOX colorectal cancer (CRC) |
| IrinotecanAlso: Campto, CamptosarStandard of Care chemotherapy | Drug | IMM-101 + FOLFIRINOX panc ca, IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC) |
| OxaliplatinAlso: EloxatinStandard of Care chemotherapy | Drug | IMM-101 + FOLFIRINOX panc ca, IMM-101+FOLFOX colorectal cancer (CRC) |
| cetuximabAlso: ErbituxStandard of Care immunotherapy | Biological | IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC) |
| Anti-PD1Also: pembrolizumab (KEYTRUDA),, nivolumab (OPDIVO)Standard of Care immunotherapy | Biological | IMM-101+ anti-programmed death-1 (PD1) lung ca, IMM-101+ anti-programmed death-1 (PD1) melanoma |
| IpilimumabAlso: YERVOYStandard of Care immunotherapy | Biological | IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma |
| CyclophosphamideAlso: cytophosphaneStandard of Care chemotherapy | Drug | IMM-101+cyclophosphamide |
Primary outcome
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.
4 secondary outcomes
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)
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.
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cunningham, MD FRCP principal investigator
Royal Marsden Hospital Foundation Trust
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMM-101, Gemcitabine and Nab-paclitaxel in people with Metastatic Cancer, run by Immodulon Therapeutics Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.