NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (KEYNOTE A60)

  • STATUS
    Recruiting
  • End date
    May 20, 2024
  • participants needed
    238
  • sponsor
    NeoImmuneTech
Updated on 24 July 2022
cancer
tyrosine
monoclonal antibodies
measurable disease
fluorouracil
kinase inhibitor
BRAF
oxaliplatin
capecitabine
immunohistochemistry
gemcitabine
pembrolizumab
ROS1
EGFR
irinotecan
programmed cell death 1 ligand 1
cancer chemotherapy
solid tumour
ovarian cancer
immunostimulant
cancer of the ovary
proto-oncogene tyrosine-protein kinase ros

Summary

The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors:

  • Safety and tolerability of NT-I7 in combination with pembrolizumab
  • Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D)

The main purpose of Phase 2a of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in participants with checkpoint inhibitor (CPI) treated and naïve relapsed and refractory (R/R) tumors.

The main purpose of the Biomarker Cohort is to assess a potential correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits in participants with CPI-naïve R/R ovarian cancer (OC).

Description

This is a multicenter, open-label Phase 1b/2a study of NT-I7 in combination with pembrolizumab. The study consists of a dose escalation phase (Phase 1b) followed by a dose expansion phase (Phase 2a) and a Biomarker Cohort.

The Phase 1b is designed to assess the safety and tolerability, including determination of the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7.

The main purpose of Phase 2a of this study is to assess the preliminary antitumor activity of NT-I7 in combination with pembrolizumab in participants with relapsed/refractory

  • checkpoint inhibitor (CPI)-treated Triple Negative Breast Cancer (TNBC), Non-small Cell Lung Cancer (NSCLC), and Small Cell Lung Cancer (SCLC)
  • checkpoint inhibitor (CPI)-naïve Microsatellite Stable Colorectal Cancer (MSS-CRC), and Pancreatic Cancer (PC) The Biomarker Cohort is designed to assess the correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits of NT-I7 in combination with pembrolizumab in participants with CPI naïve R/R Ovarian Cancer (OC).

Details
Condition 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
Treatment Pembrolizumab, NT-I7
Clinical Study IdentifierNCT04332653
SponsorNeoImmuneTech
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

(Participants must meet all the following to be eligible)
Participants with histologically or cytologically confirmed advanced or metastatic solid tumors
Have measurable disease per RECIST v1.1
Participants enrolling in the Phase 1b, Arms I, IV, IVa, V, and Va of the Phase 2a, and the Biomarker Cohort OC must have biopsiable disease
Female participants who are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; female participants of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use dual methods of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7)
Non-sterile male participants who are sexually active with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use highly effective method(s) of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7)
Meet the requirements for the intended stages and arms (disease specific inclusion criteria), as follows
Applicable to the Dose escalation phase (Phase 1b) only: (Biopsy Arm)
Relapsed/refractory advanced solid tumors
Applicable to the Dose expansion phase (Phase 2a) only
Anti-PD-1/anti-PD-L1 refractory criteria for CPI-treated TNBC, NSCLC, and SCLC
Has received at least 2 doses of an approved anti-PD-1/anti-PD-L1 monoclonal antibody (mAb)
Has demonstrated disease progression after anti-PD-1/anti-PD-L1
Specific to Arm I: CPI-treated R/R TNBC (Biopsy Arm)
Histopathologic or cytologic documented TNBC
Received one or more prior therapies for TNBC in the advanced or metastatic setting, and prior treatment (for advanced, metastatic or (neo) adjuvant)
Specific to Arm II: CPI-treated R/R NSCLC
Had prior treatment with CPI. Participants with estimated glomerular filtration rate (EGFR), BRAF, or c-ros oncogene 1(ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations are required to have received prior therapy with the appropriate tyrosine kinase inhibitor (TKI)
Specific to Arm III: CPI-treated R/R SCLC
Recurrent extensive-stage SCLC; Received prior CPI therapy
Specific to Arm IV and IVa: CPI-naïve R/R MSS-CRC (Biopsy Arm)
MSS-CRC (categorized as MSS by immunohistochemistry(IHC) or polymerase chain reaction (PCR)
Previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan; participants treated with CPI are not eligible
Specific to Arm V and Va: CPI-naïve R/R Pancreatic Cancer (Biopsy Arm)
Have documented radiographic progression to or documented in tolerance of first line systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine); participants treated previously with CPI are not eligible
Specific to Biomarker Cohort: CPI-naïve R/R Ovarian Cancer
Up to 5 prior lines of treatment, including platinum-based treatment(s); participants treated previously with CPIs are not eligible
Willing to provide pre- and on-treatment tumor biopsies

Exclusion Criteria

Pregnant, lactating or breastfeeding
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if stable
Participants who have received treatment with systemic immunosuppressive medications
Receiving chemotherapy or any anti-cancer therapy (approved or investigational) with half-life <1 week within 30 days or 5 half-lives
Has a history of non-infectious pneumonitis that required steroids or current pneumonitis
Has had an allogenic tissue/solid organ transplant or bone marrow transplant
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) and was discontinued from that treatment due to a Grade 3 or higher Immune related adverse event (irAE)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note