NCT03901573 is a Phase 1, PHASE2 clinical trial of NT-I7 in Melanoma, sponsored by NeoImmuneTech.

Who is sponsoring NCT03901573?

NCT03901573 is sponsored by NeoImmuneTech.

What drugs are being tested in NCT03901573?

Interventions in NCT03901573: NT-I7, atezolizumab.

What condition does NCT03901573 study?

NCT03901573 studies Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma.

Is NCT03901573 still recruiting?

NCT03901573 is currently terminated. Last updated 22 October 2025.

Are results published for NCT03901573?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-22 · How we verify

NCT03901573

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High-Risk Skin Cancers With Atezolizumab Plus NT-I7

Terminated Phase 1, PHASE2 Results posted Last updated 22 October 2025

What this trial tests

Phase 1, PHASE2 trial testing NT-I7 in Melanoma in 31 participants. Terminated before completion.

Timeline

26 December 2019

Primary endpoint
15 August 2023

15 August 2023

Quick facts

Lead sponsor	NeoImmuneTech
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	26 December 2019
Primary completion	15 August 2023
Estimated completion	15 August 2023
Sites	8 locations across United States

Drugs / interventions tested

NT-I7 — full drug profile →
atezolizumab (atezolizumab) — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →
Merkel Cell Carcinoma — all drugs for Merkel Cell Carcinoma →
Cutaneous Squamous Cell Carcinoma — all drugs for Cutaneous Squamous Cell Carcinoma →

Sponsor

NeoImmuneTech — full company profile →

Who can join

18 and older, any sex, with Melanoma or Merkel Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Incidence of Treatment-Related TEAE

Group	Value	95% CI
Phase 1b-Dose Level 1	3
Phase 1b-Dose Level 2	3
Phase 1b-Dose Level 3	7
Phase 1b-Dose Level 4	3
Phase 2-	14

Patient Incidence of Serious Treatment-Emergent Adverse Events

Group	Value	95% CI
Phase 1b-Dose Level 1	1
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	5
Phase 1b-Dose Level 4	1
Phase 2-	9

Patient Incidence of Serious Treatment-Related Adverse Events

Group	Value	95% CI
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	3
Phase 1b-Dose Level 4	0
Phase 2-	4

Patient Incidence of Adverse Events of Special Interest

Group	Value	95% CI
Phase 1b-Dose Level 1	2
Phase 1b-Dose Level 2	1
Phase 1b-Dose Level 3	3
Phase 1b-Dose Level 4	0
Phase 2-	9

Experienced a DLT

Group	Value	95% CI
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	1
Phase 1b-Dose Level 4	0
Phase 2-	0

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

Group	Value	95% CI
NT-I7 Dose Levels + Atezolizumab (120-840 µg/kg)	0
NT-I7 Dose Levels + Atezolizumab (1200 µg/kg)	0
NT-I7 Dose Levels + Atezolizumab (120-840 µg/kg)	0
NT-I7 Dose Levels + Atezolizumab (1200 µg/kg)	2
NT-I7 Dose Levels + Atezolizumab (120-840 µg/kg)	9
NT-I7 Dose Levels + Atezolizumab (1200 µg/kg)	6
NT-I7 Dose Levels + Atezolizumab (120-840 µg/kg)	3
NT-I7 Dose Levels + Atezolizumab (1200 µg/kg)	7

To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab Secondary · 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.

Baseline

Group	Value	95% CI
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	0
Phase 1b-Dose Level 4	0
Phase 2-	1
Phase 1b-Dose Level 1	3
Phase 1b-Dose Level 2	3
Phase 1b-Dose Level 3	7
Phase 1b-Dose Level 4	3
Phase 2-	12
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	0
Phase 1b-Dose Level 4	0
Phase 2-	2

C2D1

Group	Value	95% CI
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	1
Phase 1b-Dose Level 3	4
Phase 1b-Dose Level 4	0
Phase 2-	2
Phase 1b-Dose Level 1	3
Phase 1b-Dose Level 2	2
Phase 1b-Dose Level 3	2
Phase 1b-Dose Level 4	3
Phase 2-	11
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	1
Phase 1b-Dose Level 4	0
Phase 2-	2

End of Treatment

Group	Value	95% CI
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	0
Phase 1b-Dose Level 4	0
Phase 2-	0
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	1
Phase 1b-Dose Level 3	0
Phase 1b-Dose Level 4	0
Phase 2-	6
Phase 1b-Dose Level 1	3
Phase 1b-Dose Level 2	2
Phase 1b-Dose Level 3	7
Phase 1b-Dose Level 4	3
Phase 2-	9

90-Day Follow up

Group	Value	95% CI
Phase 1b-Dose Level 1	2
Phase 1b-Dose Level 2	2
Phase 1b-Dose Level 3	4
Phase 1b-Dose Level 4	3
Phase 2-	4
Phase 1b-Dose Level 1	1
Phase 1b-Dose Level 2	1
Phase 1b-Dose Level 3	3
Phase 1b-Dose Level 4	0
Phase 2-	11
Phase 1b-Dose Level 1	0
Phase 1b-Dose Level 2	0
Phase 1b-Dose Level 3	0
Phase 1b-Dose Level 4	0
Phase 2-	0

To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab Secondary · 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.

Duration of stable disease

Group	Value	95% CI
NT-I7 Dose Levels (NT-I7 120-840 µg/kg) + Atezolizumab	2.2	1.41 – 12.25
NT-I7 Dose Levels (1200 µg/kg) + Atezolizumab	2.0	1.45 – 2.27

Progression -Free Survival, RECIST 1.1

Group	Value	95% CI
NT-I7 Dose Levels (NT-I7 120-840 µg/kg) + Atezolizumab	4.2	2.07 – 6.93
NT-I7 Dose Levels (1200 µg/kg) + Atezolizumab	3.5	1.87 – 4.24

Overall Survival

Group	Value	95% CI
NT-I7 Dose Levels (NT-I7 120-840 µg/kg) + Atezolizumab	11.1	3.81 – 22.24
NT-I7 Dose Levels (1200 µg/kg) + Atezolizumab	NA	5.06 – NA

To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR) Secondary · 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.

Group	Value	95% CI
NT-I7 Dose Levels (NT-I7 120-840 µg/kg) + Atezolizumab	75.0
NT-I7 Dose Levels (1200 µg/kg) + Atezolizumab	53.3

Adverse events — posted to ClinicalTrials.gov

Time frame: On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1b-Dose Level 1

Serious: 1/3 (33%)

Deaths: 2/3

Phase 1b-Dose Level 2

Serious: 0/3 (0%)

Deaths: 3/3

Phase 1b-Dose Level 3

Serious: 5/7 (71%)

Deaths: 5/7

Phase 1b-Dose Level 4

Serious: 1/3 (33%)

Deaths: 1/3

Phase 2-

Serious: 9/15 (60%)

Deaths: 8/15

Serious adverse events (25 terms)

Reaction	System	Phase 1b-Dose Level 1	Phase 1b-Dose Level 2	Phase 1b-Dose Level 3	Phase 1b-Dose Level 4	Phase 2-
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—	—
Immune-mediated hepatitis	Hepatobiliary disorders	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—
Endocarditis	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Loss of personal independence in daily activities	Social circumstances	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—

Other adverse events (162 terms — click to expand)

Reaction	System	Phase 1b-Dose Level 1	Phase 1b-Dose Level 2	Phase 1b-Dose Level 3	Phase 1b-Dose Level 4	Phase 2-
Fatigue	General disorders	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—	—
Hypophosphatasemia	Metabolism and nutrition disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Blood alkaline phosphatase	Investigations	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—
Brain natriuretic peptide increased	Investigations	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—
Abnormal loss of weight	Metabolism and nutrition disorders	—	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Metabolism and nutrition disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Hematuria	Renal and urinary disorders	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—

Most-reported serious reactions: Dehydration, Acute kidney injury, Anaemia, Adrenal insufficiency, Abdominal pain, Nausea, Vomiting, Fatigue.

Data from ClinicalTrials.gov NCT03901573 adverse events section.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The Role of IL-7 and IL-7R in Cancer Pathophysiology and Immunotherapy.
Wang C, Kong L, Kim S, Lee S, et al · · 2022 · cited 78× · PMID 36142322 · DOI 10.3390/ijms231810412
Engineering cytokines for cancer immunotherapy: a systematic review.
Fu Y, Tang R, Zhao X. · · 2023 · cited 36× · PMID 37483629 · DOI 10.3389/fimmu.2023.1218082
The application of Interleukin-2 family cytokines in tumor immunotherapy research.
Zhou Y, Quan G, Liu Y, Shi N, et al · · 2023 · cited 32× · PMID 36936961 · DOI 10.3389/fimmu.2023.1090311
Hybrid Fc-fused interleukin-7 induces an inflamed tumor microenvironment and improves the efficacy of cancer immunotherapy.
Kim JH, Kim YM, Choi D, Jo SB, et al · · 2020 · cited 26× · PMID 32994996 · DOI 10.1002/cti2.1168
Immune Checkpoint Inhibition in Non-Melanoma Skin Cancer: A Review of Current Evidence.
Stonesifer CJ, Djavid AR, Grimes JM, Khaleel AE, et al · · 2021 · cited 25× · PMID 34988009 · DOI 10.3389/fonc.2021.734354
Immunotherapy for Cutaneous Squamous Cell Carcinoma: Results and Perspectives.
Alberti A, Bossi P. · · 2021 · cited 24× · PMID 35070956 · DOI 10.3389/fonc.2021.727027
Immune Checkpoint Blockade in Advanced Cutaneous Squamous Cell Carcinoma: What Do We Currently Know in 2020?
Wessely A, Steeb T, Leiter U, Garbe C, et al · · 2020 · cited 23× · PMID 33291277 · DOI 10.3390/ijms21239300
Merkel Cell Carcinoma from Molecular Pathology to Novel Therapies.
Stachyra K, Dudzisz-Śledź M, Bylina E, Szumera-Ciećkiewicz A, et al · · 2021 · cited 21× · PMID 34208339 · DOI 10.3390/ijms22126305

Verify or expand the search:

Other trials of NT-I7

Trials testing the same drug.

NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
NCT07052305 — NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Sub · Phase 1 · recruiting
NCT04498325 — Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance · Phase 1 · withdrawn
NCT04781309 — NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Pr · EARLY_PHASE1 · completed
NCT04594811 — NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma · Phase 1 · terminated

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other NeoImmuneTech trials

Trials by the same sponsor.

NCT05075603 — Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy · Phase 1 · completed
NCT04594811 — NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma · Phase 1 · terminated
NCT04501796 — A Trial of NT-I7 in COVID-19 (SPESELPIS) · Phase 1 · terminated
NCT04332653 — NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03901573 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NeoImmuneTech
Last refreshed: 22 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03901573.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing