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

  • STATUS
    Recruiting
  • End date
    May 10, 2024
  • participants needed
    84
  • sponsor
    NeoImmuneTech
Updated on 10 October 2022
metastatic melanoma
cancer
systemic therapy
carcinoma
skin cancer
squamous cell carcinoma
BRAF
pd-l1
ipilimumab
mek inhibitor
braf inhibitor
atezolizumab
merkel cell carcinoma

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)

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).

Details
Condition Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
Treatment Atezolizumab, NT-I7
Clinical Study IdentifierNCT03901573
SponsorNeoImmuneTech
Last Modified on10 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Patients who have leptomeningeal disease
of study treatment, except for prior anti-PD-L1/anti-PD-1, which requires a 3-week
Patients with autoimmune disease history
washout period
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
Patients with active tuberculosis (TB)
plus a T-cell growth factor, e.g., IL-2 (NTKR-204), IL-15 (ALT-803) or IL-7 (CYT107)
Patients who have severe infections within 4 weeks prior to Cycle 1, Day 1
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 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 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
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