Trial · NCT03009058
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
NCT03009058, Phase 1, Phase 2, Terminated, Immodulon Therapeutics Ltd; results first posted 2024-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer. Trials, record NCT03009058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03009058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
- NCT number
- NCT03009058
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Immodulon Therapeutics Ltd
- Conditions
- Metastatic Cancer
- Interventions
- IMM-101, Gemcitabine, Nab-paclitaxel, Capecitabine, Folinic Acid, Fluorouracil, Irinotecan, Oxaliplatin, cetuximab, Anti-PD1, Ipilimumab, Cyclophosphamide
- First posted
- 2017-01-04
- Last updated
- 2024-11-25
- Other registries' IDs
- eudract:2016-001459-28
- Results first posted
- 2024-11-25
- Limitations and caveats
Only two patients were enrolled into the study before the study was terminated early by the Sponsor for commercial reasons. There were no specific safety concerns based on the data from the two patients treated. These limited data provide some preliminary indication regarding the safety and tolerability of IMM-101 when administered in combination with nivolumab. No meaningful assessment of efficacy could be made given that only two patients were enrolled into the study.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 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. |
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Week 28 through study completion (maximum 4.5 years) | Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions. |
| Secondary | Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor | From screening until study termination an average of 3 months. | 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 |
| Secondary | Response to Treatment | Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients | 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). |
| Secondary | Overall Survival (OS) | From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. | Assessment of overall survival (defined as the time from enrolment to death due to any cause). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months. | Both patients were assessed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Week 28 through study completion (maximum 4.5 years) | Study was terminated before the Week 28 timepoint was reached. | ||
| SECONDARY | Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor | From screening until study termination an average of 3 months. | Both patients enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response to Treatment | Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. | Assessment of overall survival (defined as the time from enrolment to death due to any cause). However, whilst 2 participants were monitored and analyzed, neither patient died before the study was terminated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | Participants | ||
| Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | Participants | ||
| Response to Treatment | IMM-101 in Combination With Anti PDL1 in Melanoma | immune related Stable Disease [irSD] | 1 | Participants | |
| Response to Treatment | IMM-101 in Combination With Anti PDL1 in Melanoma | immune related Partial Response [irPR] | 1 | Participants | |
| Response to Treatment | IMM-101 in Combination With Anti PDL1 in Melanoma | immune related Complete Response [irCR] | 0 | Participants | |
| Overall Survival (OS) | IMM-101 in Combination With Anti PDL1 in Melanoma | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMM-101 in Combination With Anti PDL1 in Melanoma | 2 | |
| Overall Study | COMPLETED | IMM-101 in Combination With Anti PDL1 in Melanoma | 0 | |
| Overall Study | NOT COMPLETED | IMM-101 in Combination With Anti PDL1 in Melanoma | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural pain | Injury, poisoning and procedural complications | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | 2 | 1 |
| other | Hyperthyroidism | Endocrine disorders | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | 2 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | 2 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMM-101 in Combination With Anti PDL1 in Melanoma | 0 | 2 |
| Total, other adverse events | IMM-101 in Combination With Anti PDL1 in Melanoma | 1 | 2 |
| Total, serious adverse events | IMM-101 in Combination With Anti PDL1 in Melanoma | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03009058
GET https://conductscience.org/api/trials/v1/NCT03009058/registered