Trial · NCT03901573
High-Risk Skin Cancers With Atezolizumab Plus NT-I7
NCT03901573, Phase 1, Phase 2, Terminated, NeoImmuneTech; results first posted 2025-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. High-Risk Skin Cancers With Atezolizumab Plus NT-I7. Trials, record NCT03901573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03901573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Risk Skin Cancers With Atezolizumab Plus NT-I7
- NCT number
- NCT03901573
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- NeoImmuneTech
- Conditions
- Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
- Interventions
- NT-I7, atezolizumab
- First posted
- 2019-04-03
- Last updated
- 2025-10-22
- Results first posted
- 2025-10-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | 1. On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment) 2.First 21 days (C1/D1 through Day 21) | 1. Incidence, nature, and severity of adverse events graded according to NCI CTCAE 5.0 2. Incidence and nature of dose-limiting toxicities (DLTs) Note: ORR (Defined as the percentage of patients who have at least one confirmed partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1). ORR is included in Phase 2a Primary Outcome Measure. |
| Primary | Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator | C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year | Pooling of dose levels for this Outcome Measure was pre-specified in the Statistical Analysis Plan (SAP Section 4.2.1) and the study protocol. Phase 1b dose-escalation results are summarized by dose level (120, 360, 840, 1200 µg/kg), and Phase 2a results under 1200 µg/kg. Efficacy analyses pool Phase 1b doses (120-840 µg/kg) and the Phase 2a 1200 µg/kg dose to reflect the predefined analysis strategy and study objectives. This approach was chosen due to small sample sizes and early study termination, as documented in the Clinical Study Report (CSR). |
| Secondary | To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab | C1D1 through end of 90-day follow-up | The ADA status will be defined using the baseline and postbaseline results. Anti-drug antibody negative is defined as negative results at all time points. Anti-drug antibody positive is defined as a positive result at any time point, including baseline. |
| Secondary | To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab | C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year | Pooling of dose levels for this Outcome Measure was also pre-specified in the SAP and study protocol to maintain consistency across efficacy endpoints. For this Outcome Measure (e.g., Disease Control Rate), pooled groups were defined as Phase 1b (120-840 µg/kg) and Phase 2a (1200 µg/kg). This approach aligns with the predefined analyses and study objectives and prevents misleading subgroup estimates given the limited enrollment and early study termination. |
| Secondary | To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR) | C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year | For Outcome Measure 4 and 5, pooling was also pre-specified in SAP Section 4.8 and CSR Section 11.4. Kaplan-Meier analyses were conducted on pooled groups for interpretability and statistical validity. Separate reporting by Arm was not feasible due to small sample sizes and early termination. |
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 | Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | 1. On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment) 2.First 21 days (C1/D1 through Day 21) | Safety: All patients who receive at least 1 dose of the investigational regimen ; DLT: All patients who receive at least 1 dose of the investigational regimen and complete the full 3-week DLT window or who do not complete the full 3-week DLT window due to the occurrence of a DLT.; Analyses of adverse events will be performed for those events that are considered treatment emergent.(Subjects with one or more AEs within a level of MedDRA are counted only once in that level) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator | C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year | The Arm/Group has been categorized based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W.treatment and have at least one evaluable post baseline tumor assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab | C1D1 through end of 90-day follow-up | All patients who receive at least 1 dose of the investigational regimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab | C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year | Defined as the time from the first occurrence of stable disease or better (PR or CR or SD) to the time of the first documented disease progression or death from any cause, whichever occurs first per RECIST v1.1. The Arm/Group has been categorized based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W. | Months | MEDIAN |
| SECONDARY | To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR) | C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year | All patients who received at least one cycle of study treatment and have at least one evaluable post baseline tumor assessment. The Arm/Group has been categorized based on the dosing regimen of NT-I7 per study design: Phase 1b, DL1-3 every 3 weeks (Q3W); Phase 1b DL4 and Phase 2a, Q6W. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group101
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 1 | Incidence of Treatment-Related TEAE | 3 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 2 | Incidence of Treatment-Related TEAE | 3 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 3 | Incidence of Treatment-Related TEAE | 7 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 4 | Incidence of Treatment-Related TEAE | 3 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 2- | Incidence of Treatment-Related TEAE | 14 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 1 | Patient Incidence of Serious Treatment-Emergent Adverse Events | 1 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 2 | Patient Incidence of Serious Treatment-Emergent Adverse Events | 0 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 3 | Patient Incidence of Serious Treatment-Emergent Adverse Events | 5 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 1b-Dose Level 4 | Patient Incidence of Serious Treatment-Emergent Adverse Events | 1 | Participants | |
| Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose | Phase 2- | Patient Incidence of Serious Treatment-Emergent Adverse Events | 9 | Participants |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b-Dose Level 1 | 3 | |
| Overall Study | STARTED | Phase 1b-Dose Level 2 | 3 | |
| Overall Study | STARTED | Phase 1b-Dose Level 3 | 7 | |
| Overall Study | STARTED | Phase 1b-Dose Level 4 | 3 | |
| Overall Study | STARTED | Phase 2- | 15 | |
| Overall Study | COMPLETED | Phase 1b-Dose Level 1 | 2 | |
| Overall Study | COMPLETED | Phase 1b-Dose Level 2 | 2 | |
| Overall Study | COMPLETED | Phase 1b-Dose Level 3 | 4 | |
| Overall Study | COMPLETED | Phase 1b-Dose Level 4 | 3 | |
| Overall Study | COMPLETED | Phase 2- | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events935
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 | Anemia | Blood and lymphatic system disorders | Phase 1b-Dose Level 1 | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1b-Dose Level 2 | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1b-Dose Level 3 | 0 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1b-Dose Level 4 | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 2- | 0 | 15 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Phase 1b-Dose Level 1 | 1 | 3 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Phase 1b-Dose Level 2 | 0 | 3 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Phase 1b-Dose Level 3 | 1 | 7 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Phase 1b-Dose Level 4 | 0 | 3 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Phase 2- | 0 | 15 |
1 to 10 of 935Source ClinicalTrials.gov
See all 935 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b-Dose Level 1 | 2 | 3 |
| Total, all-cause mortality | Phase 1b-Dose Level 2 | 3 | 3 |
| Total, all-cause mortality | Phase 1b-Dose Level 3 | 5 | 7 |
| Total, all-cause mortality | Phase 1b-Dose Level 4 | 1 | 3 |
| Total, all-cause mortality | Phase 2- | 8 | 15 |
| Total, other adverse events | Phase 1b-Dose Level 1 | 3 | 3 |
| Total, other adverse events | Phase 1b-Dose Level 2 | 3 | 3 |
| Total, other adverse events | Phase 1b-Dose Level 3 | 7 | 7 |
| Total, other adverse events | Phase 1b-Dose Level 4 | 3 | 3 |
| Total, other adverse events | Phase 2- | 14 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT03901573
GET https://conductscience.org/api/trials/v1/NCT03901573/results?page=2