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REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NKTR-255
Durvalumab
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 years or older Histologic diagnosis of non-small cell lung cancer Written consent obtained before initiation of any study-related procedures Definitive cancer treatment intent Absence of current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years and who are deemed at low risk for recurrence are eligible for the study. Adequate liver (AST, ALT, Alk Phos, and Tbili <2 fold upper limit) and kidney function (Cr < 2.5 limit of normal and Cr clearance >30) ECOG 0-2 Exclusion Criteria: Subjects are to be excluded from the study if any of the following conditions apply: HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response); History of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis, or inflammatory disease. Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator. Known or suspected hypersensitivity to any component of the investigational product Recurrent radiation to the treatment site Prior major surgery within 4 weeks of enrollment from which the patient has not recovered Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results Previous enrollment in this study Pregnancy: a female subject defined as a WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. Patients must be capable of understanding and providing a written informed consent. Patients with leukemias or lymphomas with T cell/histiocyte or NK cell rich component(s) and other variants not otherwise specified that contain high numbers of T or NK cells. Evidence of clinically significant interstitial lung disease or active noninfectious pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1. Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by the end of chemoradiation. Prior exposure to IL-2 or IL-5.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NKTR-255 combination (Durvalumab)

Arm Description

Participants will receive vein over about 30 minutes. Participants receive the first dose within 72 hours (3 days) after you complete CRT and the second dose at 3 weeks after you complete CRT. Then, you will receive NKTR-255 one (1) time every 4 weeks after that for up to 1 year. Durvalumab Participants will receive durvalumab by vein over about 30 minutes. You will receive the first dose at 3 weeks after you complete CRT therapy. Then, you will receive durvalumab one (1) time every 4 weeks after that for up to 1 year

Outcomes

Primary Outcome Measures

Overall survival time distribution

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
October 13, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05632809
Brief Title
REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)
Official Title
REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Nektar Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To learn about the effects of the investigational drug NKTR-255 in combination with the standard drug durvalumab on locally advanced NSCLC when given after CRT.
Detailed Description
Primary Objectives: Estimate the level of lymphocyte restoration after administration of NKTR-255 concurrently with durvalumab after chemoradiation. Absolute lymphocyte will be obtained along with changes in levels of NK cells, CD4 T cells, CD8 T cells, and B cells from baseline. Monitor the safety of NKTR-255, which includes treatment related grade 3+ radiation pneumonitis Secondary Objectives: Estimate the Progression-free survival time distribution Estimate the Overall survival time distribution Exploratory objectives: Characterize pharmacokinetics of NKTR-255 and assess immunogenicity of NKTR-255 Characterize pharmacodynamic effects and changes in activation markers and proliferation of NK and CD8 T cells, and cytokine levels after administration of NKTR-255 in combination with Durvalumab Assess the correlation between ctDNA and efficacy measurements

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NKTR-255 combination (Durvalumab)
Arm Type
Experimental
Arm Description
Participants will receive vein over about 30 minutes. Participants receive the first dose within 72 hours (3 days) after you complete CRT and the second dose at 3 weeks after you complete CRT. Then, you will receive NKTR-255 one (1) time every 4 weeks after that for up to 1 year. Durvalumab Participants will receive durvalumab by vein over about 30 minutes. You will receive the first dose at 3 weeks after you complete CRT therapy. Then, you will receive durvalumab one (1) time every 4 weeks after that for up to 1 year
Intervention Type
Drug
Intervention Name(s)
NKTR-255
Intervention Description
Given by IV (vein)
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Given by IV (vein)
Primary Outcome Measure Information:
Title
Overall survival time distribution
Time Frame
through study completion; an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Histologic diagnosis of non-small cell lung cancer Written consent obtained before initiation of any study-related procedures Definitive cancer treatment intent Absence of current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years and who are deemed at low risk for recurrence are eligible for the study. Adequate liver (AST, ALT, Alk Phos, and Tbili <2 fold upper limit) and kidney function (Cr < 2.5 limit of normal and Cr clearance >30) ECOG 0-2 Exclusion Criteria: Subjects are to be excluded from the study if any of the following conditions apply: HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response); History of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis, or inflammatory disease. Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator. Known or suspected hypersensitivity to any component of the investigational product Recurrent radiation to the treatment site Prior major surgery within 4 weeks of enrollment from which the patient has not recovered Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results Previous enrollment in this study Pregnancy: a female subject defined as a WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. Patients must be capable of understanding and providing a written informed consent. Patients with leukemias or lymphomas with T cell/histiocyte or NK cell rich component(s) and other variants not otherwise specified that contain high numbers of T or NK cells. Evidence of clinically significant interstitial lung disease or active noninfectious pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1. Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by the end of chemoradiation. Prior exposure to IL-2 or IL-5.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven H. Lin, MD
Phone
(713) 563-8490
Email
shlin@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Lin, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven H. Lin, MD
First Name & Middle Initial & Last Name & Degree
Steven H. Lin, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

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REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)

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