Trial · NCT04332653
NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT04332653, Phase 1, Phase 2, Completed, NeoImmuneTech; results first posted 2026-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors. Trials, record NCT04332653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04332653
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- NCT number
- NCT04332653
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 215 participants, actual
- Lead sponsor
- NeoImmuneTech
- Conditions
- Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer
- Interventions
- NT-I7, pembrolizumab (KEYTRUDA®)
- First posted
- 2020-04-03
- Last updated
- 2026-03-09
- Results first posted
- 2026-02-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Up to 2 years and 3 months | A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes: 1. Death; 2. A life-threatening AE; 3. An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; 4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; 5. A congenital anomaly/birth defect; 6. Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Primary | Phase 1b: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Up to 21 days | A DLT was defined as any AE occurring within the first 21 days that was considered to be related to the trial treatments (NT-I7 and/or pembrolizumab) per the investigator, and that met at least one of the non-hematologic or hematologic criteria: * Grade 4 non-hematologic toxicity * Grade ≥ 3 diarrhea, nausea and vomiting * Grade ≥ 3 rash for ≥ 5 days * Grade 4 neutropenia for ≥ 5 days * Febrile neutropenia Grade 3 or Grade 4 * Other Grade 4 hematologic toxicity for ≥7 days, except thrombocytopenia * Any non-hematologic AE ≥ Grade 3 in severity * Any Grade 3 or Grade 4 non-hematologic laboratory value if medical intervention was required, led to hospitalization, persisted for \> 1 week, resulted in potential drug-induced liver injury * Other Grade ≥ 3 clinical laboratory abnormalities not reversible to ≤ Grade 1 within 72 hours * Prolonged delay in initiating Cycle 2 * Any treatment-related toxicity that caused treatment discontinuation in Cycle 1 * Grade 5 toxicity. |
| Primary | Phase 2a (Arms I to Va): Objective Response Rate (ORR) | Up to 2 years | ORR was defined as the percentage of participants who had at least one confirmed partial response (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) and immune RECIST (iRECIST) as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs) | Pre-treatment and post-treatment (maximum duration of treatment of approximately 2 years) | CD8 positivity TILs in tumor biopsy samples were identified using a validated immunohistochemistry (IHC) assay and certified by a pathologist. The percentage of area occupied by TILs was evaluated in the stroma area, tumor area and tumor - relevant tissue area both pre- and post-treatment. |
| Secondary | Biomarker Cohort: ORR | Up to 2 years | ORR was defined as the percentage of participants who had at least one confirmed PR or CR, per RECIST v1.1 and iRECIST as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 1b/2a: Duration of Objective Response (DOR) | Up to 2 years | DOR was defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. |
| Secondary | Phase 1b/2a: Disease Control Rate (DCR) | Up to 2 years | DCR was defined as the proportion of participants with a best overall response of CR, PR, stable disease (SD) per RECIST 1.1 and iRECIST as determined by the investigator.. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) at least a 20% increase in the sum of the diameters of target lesions), taking as reference the smallest sum diameters while on study. |
| Secondary | Phase 1b/2a: Progression Free Survival (PFS) | Up to 2 years | PFS was defined as the time from the first trial treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first per RECIST 1.1 and iRECIST as determined by the investigator. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, using the smallest sum observed on study as reference, with an absolute increase of at least 5 mm, or the appearance of new lesions, or unequivocal progression of non-target lesions, per RECIST 1.1. |
| Secondary | Phase 1b/2a: Overall Survival (OS) | Up to 2 years | OS was defined as the time from first trial treatment (Cycle 1, Day 1) to death from any cause. |
| Secondary | Phase 1b/2a: Number of Participants Who Experienced an Increase in Anti-Drug Antibodies (ADAs) to NT-I7 | Up to 2 years | Immunogenicity to NT-I7 was measured using a risk-based, tiered testing approach. This included screening and confirmatory assays for binding ADAs, epitope-specific assays to characterize ADA reactivity to whole NT-I7 vs IL-7 domain, and a cell-based neutralizing ADA assay for IL7 bioactivity. Participants' samples were obtained at baseline and over the course of treatment (to evaluate the prevalence and incidence of treatment-emergent/boosted ADA). Not detected or detected but not confirmed ADA was defined as negative. Detected and confirmed ADA was defined as positive. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Up to 2 years and 3 months | Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. Only participants in Phase 1b were analyzed for this Outcome Measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Up to 21 days | DLT Evaluable Analysis Set: all participants in Phase 1b portion of the study who were in safety analysis set and have completed the first 21 days (3 weeks) of study treatment (Cycle 1, Day 1 to 21) or any subjects who have not completed 21 days due to DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2a (Arms I to Va): Objective Response Rate (ORR) | Up to 2 years | Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medication (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. Only participants in Phase 2a (Arms I to Va) were analyzed for this Outcome Measure. | percentage of participants | NUMBER |
| PRIMARY | Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs) | Pre-treatment and post-treatment (maximum duration of treatment of approximately 2 years) | Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. Only participants with positive CD8 marker were included. | percentage of area occupied | MEAN |
| SECONDARY | Biomarker Cohort: ORR | Up to 2 years | Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medication (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. Only participants in Phase 2a (Biomarker Cohort) were analyzed for this Outcome Measure. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2a: Duration of Objective Response (DOR) | Up to 2 years | Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trialmedication (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. Only participants who had a documented response were included. | months | MEDIAN |
| SECONDARY | Phase 1b/2a: Disease Control Rate (DCR) | Up to 2 years | Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medications (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2a: Progression Free Survival (PFS) | Up to 2 years | Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medications (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. | months | MEDIAN |
| SECONDARY | Phase 1b/2a: Overall Survival (OS) | Up to 2 years | Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medications (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. | months | MEDIAN |
| SECONDARY | Phase 1b/2a: Number of Participants Who Experienced an Increase in Anti-Drug Antibodies (ADAs) to NT-I7 | Up to 2 years | Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group131
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | TEAEs | 3 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 2 (NT-I7 960 ug/kg) | TEAEs | 3 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg) | TEAEs | 6 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | SAEs | 2 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 2 (NT-I7 960 ug/kg) | SAEs | 1 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg) | SAEs | 1 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | Trial Treatment-related TEAEs | 3 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 2 (NT-I7 960 ug/kg) | Trial Treatment-related TEAEs | 2 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg) | Trial Treatment-related TEAEs | 6 | Participants | |
| Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | Trial Treatment-related SAEs | 1 | Participants |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b | STARTED | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | 3 | |
| Phase 1b | STARTED | Phase 1b: Dose Level 2 (NT-I7 960 ug/kg) | 3 | |
| Phase 1b | STARTED | Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg) | 6 | |
| Phase 1b | STARTED | Phase 2a: Arm I | 0 | |
| Phase 1b | STARTED | Phase 2a: Arm II | 0 | |
| Phase 1b | STARTED | Phase 2a: Arm III | 0 | |
| Phase 1b | STARTED | Phase 2a: Arm IV | 0 | |
| Phase 1b | STARTED | Phase 2a: Arm IVa | 0 | |
| Phase 1b | STARTED | Phase 2a: Arm V | 0 | |
| Phase 1b | STARTED | Phase 2a: Arm Va | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events5,467
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 | Fatigue | General disorders | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | 1 | 3 | |
| other | Fatigue | General disorders | Phase 1b: Dose Level 2 (NT-I7 960 ug/kg) | 0 | 3 | |
| other | Fatigue | General disorders | Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg) | 4 | 6 | |
| other | Fatigue | General disorders | Phase 2a: Arm I | 4 | 16 | |
| other | Fatigue | General disorders | Phase 2a: Arm II | 14 | 34 | |
| other | Fatigue | General disorders | Phase 2a: Arm III | 8 | 17 | |
| other | Fatigue | General disorders | Phase 2a: Arm IV | 13 | 29 | |
| other | Fatigue | General disorders | Phase 2a: Arm IVa | 12 | 28 | |
| other | Fatigue | General disorders | Phase 2a: Arm V | 12 | 32 | |
| other | Fatigue | General disorders | Phase 2a: Arm Va | 16 | 34 |
1 to 10 of 5,467Source ClinicalTrials.gov
See all 5,467 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: Dose Level 1 (NT-I7 480 ug/kg) | 1 | 3 |
| Total, all-cause mortality | Phase 1b: Dose Level 2 (NT-I7 960 ug/kg) | 1 | 3 |
| Total, all-cause mortality | Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg) | 1 | 6 |
| Total, all-cause mortality | Phase 2a: Arm I | 9 | 16 |
| Total, all-cause mortality | Phase 2a: Arm II | 20 | 34 |
| Total, all-cause mortality | Phase 2a: Arm III | 12 | 17 |
| Total, all-cause mortality | Phase 2a: Arm IV | 19 | 29 |
| Total, all-cause mortality | Phase 2a: Arm IVa | 16 | 28 |
| Total, all-cause mortality | Phase 2a: Arm V | 18 | 32 |
| Total, all-cause mortality | Phase 2a: Arm Va | 24 | 34 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
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/NCT04332653
GET https://conductscience.org/api/trials/v1/NCT04332653/results?page=2