MelanomaPhase 1/2NCT03901573

High-Risk Skin Cancers With Atezolizumab Plus NT-I7

A Phase 1/2 study testing NT-I7 and atezolizumab in people with Melanoma and Merkel Cell Carcinoma, run by NeoImmuneTech at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to test whether the addition of NT-I7 to atezolizumab provides clinically meaningful outcomes for patients with anti-PD-1/PD-L1 naive or relapsed/refractory high-risk melanoma, Merkel Cell Carcinoma (MCC) and cutaneous Squamous Cell Carcinoma (cSCC) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
What is being tested?: NT-I7 and atezolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 8 sitesUnited States
Study dates: 26 Dec 2019to 15 Aug 2023
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

Patients must be ≥18 years of age on day of signing informed consent document.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
Patients must have adequate organ and marrow function.
Patients positive for HIV can be considered.
Arm I - cSCC: Patients must have biopsy-proven metastatic cSCC or locoregional cSCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy; MCC: Patients must have biopsy-proven metastatic MCC or locoregional MCC in need of systemic therapy, including patients that have not had prior systemic therapy or have recurred following standard locoregional therapy with surgery and/or radiation therapy. Prior chemotherapy is allowed.
Arm II - MCC: Patients must have biopsy-proven metastatic MCC or locoregional MCC that has recurred following anti-PD-1 or anti-PD-L1, or has SD following anti-PD-1 or anti-PD-L1, defined as 12 weeks of SD per RECIST 1.1; cSCC: Patients must have biopsy-proven metastatic cSCC or locoregional cSCC that has recurred following anti-PD-1 or anti-PD-L1, or has SD following anti-PD-1 or anti-PD-L1, defined as 12 weeks of SD per RECIST 1.1; Melanoma: Patients must have biopsy-proven metastatic melanoma or locoregional melanoma that has recurred following anti-PD-1, anti-PD-L1, or has SD following anti-PD-1 or anti-PD-L1, defined as 12 weeks of SD per RECIST 1.1.
Note: Prior therapy with ipilimumab is allowed (subject to a 6-week washout period) but not required.
Note: Progression following targeted therapies (e.g., BRAF inhibitor and/or MEK inhibitor) or other approved (e.g., talimogene laherparepvec [T-VEC]) or investigational therapies is allowed.

Who cannot join

Pregnancy, lactation, or breastfeeding.
Significant cardiovascular disease.
Poorly controlled Type 2 diabetes mellitus.
Major surgical procedure, other than for diagnosis, within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study.
Patients who have had chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or systemic mitomycin C) prior to Cycle 1, Day 1.
Patients who had prior treatment with immune CPIs, immunomodulatory monoclonal antibodies (mAbs), and/or mAb-derived therapies within 6 weeks before the initiation of study treatment, except for prior anti-PD-L1/anti-PD-1, which requires a 3-week washout period.

Show all 19Show fewer

Patients who have received treatment with any other investigational agent within 4 weeks prior to Cycle 1, Day 1.
Patients who have received treatment and failed therapy with checkpoint inhibition plus a T-cell growth factor, e.g., IL-2 (NTKR-204), IL-15 (ALT-803) or IL-7 (CYT107).
Patients with known primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) are excluded, with some exceptions.
Patients who have leptomeningeal disease.
Patients with autoimmune disease history.
Patients who have received treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1.
Patients who have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening).
Patients with active tuberculosis (TB).
Patients who have severe infections within 4 weeks prior to Cycle 1, Day 1.
Patients who have signs or symptoms of recent infection (not meeting the above criteria for severe infections) within 2 weeks before initiation of study treatment.
Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients who have received a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipate that such a live attenuated vaccine be required during the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Dana Farber
Boston, Massachusetts, 02215
MGH
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60208
Cleveland Clinic
Cleveland, Ohio, 44106
City of Hope
Duarte, California, 91010
Mt Sinai
New York, New York, 10029
Providence Portland Medical Center
Portland, Oregon, 97213
Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1b/2a, Open Label Study to Evaluate Anti-tumor Efficacy and Safety of rhIL-7-hyFc (NT-I7) in Combination With Anti-PD-L1 (Atezolizumab) in Patients With Anti-PD-1/PD-L1 naïve or Relapsed/Refractory High-risk Skin Cancers

Read the detailed description

This is a Phase 1b/2a, open-label, multicenter study to evaluate the safety, tolerability and anti-tumor effect of NT-I7 (rhIL-7-hyFc) in combination with atezolizumab (MPDL3280A, anti-PD-L1) in patients with anti-PD-1/PD-L1 naïve or relapsed/refractory high-risk skin cancers including cutaneous Squamous Cell Carcinoma (cSCC), Merkel Cell Carcinoma (MCC) and melanoma.

This study has been designed to evaluate the safety and tolerability, including the Maximum Tolerated Dose (MTD) or recommended Phase 2 dose (RP2D), of NT-I7 in combination with atezolizumab.

There are two phases to this study:

Phase 1b, a NT-I7 dose-escalation phase to determine the MTD or RP2D
Phase 2a, a non-randomized parallel dose expansion phase to confirm the MTD or RP2D in both arms.

Arm I: Anti-PD-1/PD-L1 (checkpoint inhibitors, CPI) naïve patients with cSCC and MCC

Arm II: Anti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma

Number of Patients A total of up to 84 patients will be enrolled; Up to 24 patients will be enrolled in the Phase 1b (up to 6 patients per dose level, using 3 + 3 design), and 60 patients will be enrolled in the Phase 2a (24 patients in Arm I, i.e., 12 patients for each indication, and 36 in Arm II, i.e., 12 patients for each indication).

Conditions: Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
Being tested: NT-I7, atezolizumab
Medical subject headings: Melanoma, Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NT-I7Drug
Also called efineptakin alfa, rhIL-7-hyFc
Dose Escalation (Phase 1b) - NT-I7 IM (intramuscular) on Day 1 of each Cycle until MTD or RP2D is achieved.
Dose Expansion - NT-I7 IM (intramuscular) on Day 1 of each Cycle, at Maximum Tolerated Dose (MTD) or RP2D defined in escalation phase
atezolizumabDrug
Also called Tecentriq
Dose Escalation - atezolizumab IV (intravenous) on Day 1 of each Cycle
Dose Expansion - atezolizumab IV (intravenous) on Day 1 of each Cycle

Study groups in NCT03901573
Study group	Role	What they receive
Checkpoint Inhibitor-Naive cSCC, MCC Pts	Experimental	Anti-PD-1/PD-L1 naïve patients with cSCC and MCC Receives: Drug: NT-I7; Drug: atezolizumab
Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts	Experimental	Anti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma Receives: Drug: NT-I7; Drug: atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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. 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.
Measured: 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)
Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator
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).
Measured: 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

Secondary outcomes (3)

To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
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.
Measured: C1D1 through end of 90-day follow-up
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab
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.
Measured: 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
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR)
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Dec 201915 Aug 2023

First posted3 Apr 2019
Study start26 Dec 2019
Primary completion15 Aug 2023
Study completion15 Aug 2023

Why it stopped: Strategic decision by sponsor

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 MelanomaStudies 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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03901573
Sponsor's protocol ID: NIT-106
Other IDs: ION-02
Status last verified: Oct 2025
First submitted: 26 Mar 2019
Last updated: 22 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
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Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2a, Open Label Study to Evaluate Anti-tumor Efficacy and Safety of rhIL-7-hyFc (NT-I7) in Combination With Anti-PD-L1 (Atezolizumab) in Patients With Anti-PD-1/PD-L1 naïve or Relapsed/Refractory High-risk Skin Cancers
ClinicalTrials.gov ID: NCT03901573
Acronym / sponsor ID: NIT-106
Conditions: Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic decision by sponsor
Enrolment: 31 participants (actual)
Lead sponsor: NeoImmuneTechIndustry (pharma, biotech, devices)
Collaborators: Immune Oncology Network
Study start: 26 Dec 2019 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 3 Apr 2019 (actual)
Results: Posted 22 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study has been designed to evaluate the safety and tolerability, including the Maximum Tolerated Dose (MTD) or recommended Phase 2 dose (RP2D), of NT-I7 in combination with atezolizumab.

There are two phases to this study:

Phase 1b, a NT-I7 dose-escalation phase to determine the MTD or RP2D
Phase 2a, a non-randomized parallel dose expansion phase to confirm the MTD or RP2D in both arms.

Arm I: Anti-PD-1/PD-L1 (checkpoint inhibitors, CPI) naïve patients with cSCC and MCC

Arm II: Anti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Checkpoint Inhibitor-Naive cSCC, MCC Pts	Experimental	Drug: NT-I7, Drug: atezolizumabAnti-PD-1/PD-L1 naïve patients with cSCC and MCC
Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts	Experimental	Drug: NT-I7, Drug: atezolizumabAnti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients must be ≥18 years of age on day of signing informed consent document.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
Patients must have adequate organ and marrow function.
Patients positive for HIV can be considered.
Arm I - cSCC: Patients must have biopsy-proven metastatic cSCC or locoregional cSCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy; MCC: Patients must have biopsy-proven metastatic MCC or locoregional MCC in need of systemic therapy, including patients that have not had prior systemic therapy or have recurred following standard locoregional therapy with surgery and/or radiation therapy. Prior chemotherapy is allowed.

Key exclusion criteria (19 listed)

Pregnancy, lactation, or breastfeeding.
Significant cardiovascular disease.
Poorly controlled Type 2 diabetes mellitus.
Major surgical procedure, other than for diagnosis, within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study.
Patients who have had chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or systemic mitomycin C) prior to Cycle 1, Day 1.

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
NT-I7Also: efineptakin alfa, rhIL-7-hyFcDose Escalation (Phase 1b) - NT-I7 IM (intramuscular) on Day 1 of each Cycle until MTD or RP2D is achieved. Dose Expansion - NT-I7 IM (intramuscular) on Day 1 of each Cycle, at Maximum Tolerated Dose (MTD) or RP2D defined in escalation phase	Drug	Checkpoint Inhibitor-Naive cSCC, MCC Pts, Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts
atezolizumabAlso: TecentriqDose Escalation - atezolizumab IV (intravenous) on Day 1 of each Cycle Dose Expansion - atezolizumab IV (intravenous) on Day 1 of each Cycle	Drug	Checkpoint Inhibitor-Naive cSCC, MCC Pts, Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts

Primary outcome

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
Time frame: 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.
Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator
Time frame: 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).

3 secondary outcomes

To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab
Time frame: C1D1 through end of 90-day follow-up
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab
Time frame: 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
To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR)
Time frame: 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

Results and safety

Results posted to the registry on 22 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1b-Dose Level 1	3	2
Phase 1b-Dose Level 2	3	2
Phase 1b-Dose Level 3	7	4
Phase 1b-Dose Level 4	3	3
Phase 2-	15	7

Primary outcome: 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

Time frame: 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). Count of participants. Unit: Participants

Measure	Phase 1b-Dose Level 1 n = 3	Phase 1b-Dose Level 2 n = 3	Phase 1b-Dose Level 3 n = 7	Phase 1b-Dose Level 4 n = 3	Phase 2- n = 15
Incidence of Treatment-Related TEAE	3	3	7	3	14
Patient Incidence of Serious Treatment-Emergent Adverse Events	1	0	5	1	9
Patient Incidence of Serious Treatment-Related Adverse Events	0	0	3	0	4
Patient Incidence of Adverse Events of Special Interest	2	1	3	0	9
Experienced a DLT	0	0	1	0	0

Population analysed: 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)

Primary outcome: Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator

Time frame: 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. Count of participants. Unit: Participants

Measure	NT-I7 Dose Levels + Atezolizumab (120-840 µg/kg) n = 12	NT-I7 Dose Levels + Atezolizumab (1200 µg/kg) n = 15
Complete response	0	0
Partial response	0	2
Stable disease	9	6
Progressive disease	3	7

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1b-Dose Level 1	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Phase 1b-Dose Level 2	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Phase 1b-Dose Level 3	5 of 7 (71.4%)	7 of 7 (100%)	5 of 7
Phase 1b-Dose Level 4	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Phase 2-	9 of 15 (60%)	14 of 15 (93.3%)	8 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
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.

NgocDiep Le, MD, PhD study chair

NeoImmuneTech

Martin Cheever, MD study director

Fred Hutchinson Cancer Center

Brian Gastman, MD principal investigator

The Cleveland Clinic

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NT-I7 and atezolizumab in people with Melanoma and Merkel Cell Carcinoma, run by NeoImmuneTech at 8 sites in United States.

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 8 inclusion and 19 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 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 22 Oct 2025). 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?

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 (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03901573.

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 22 Oct 2025.