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Trial Title:
REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)
NCT ID:
NCT05632809
Condition:
Lung Cancer
Conditions: Official terms:
Durvalumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NKTR-255
Description:
Given by IV (vein)
Arm group label:
NKTR-255 combination (Durvalumab)
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Given by IV (vein)
Arm group label:
NKTR-255 combination (Durvalumab)
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:
1. 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.
2. Monitor the safety of NKTR-255, which includes treatment related grade 3+ radiation
pneumonitis
Secondary Objectives:
1. Estimate the Progression-free survival time distribution
2. Estimate the Overall survival time distribution
Exploratory objectives:
1. Characterize pharmacokinetics of NKTR-255 and assess immunogenicity of NKTR-255
2. 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
3. Assess the correlation between ctDNA and efficacy measurements
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Histologic diagnosis of non-small cell lung cancer
3. Written consent obtained before initiation of any study-related procedures
4. Definitive cancer treatment intent
5. 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.
6. 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)
7. ECOG 0-2
Exclusion Criteria:
Subjects are to be excluded from the study if any of the following conditions apply:
1. HIV infection, cellular immune deficiencies, hypogammaglobulinemia or
dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
2. Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a
sustained virologic response);
3. History of clinically significant autoimmune disease, Crohn's disease, ulcerative
colitis, or inflammatory disease.
4. Serious concomitant disorder, including active systemic infection requiring
treatment, as judged by the Investigator.
5. Known or suspected hypersensitivity to any component of the investigational product
6. Recurrent radiation to the treatment site
7. Prior major surgery within 4 weeks of enrollment from which the patient has not
recovered
8. Other condition or prior therapy that, in the opinion of the Investigator,
compromises the subject's welfare or may confound study results
9. Previous enrollment in this study
10. 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.
11. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
12. Patients must be capable of understanding and providing a written informed consent.
13. 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.
14. Evidence of clinically significant interstitial lung disease or active noninfectious
pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1.
15. Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by
the end of chemoradiation.
16. Prior exposure to IL-2 or IL-5.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven H. Lin, MD
Investigator:
Last name:
Steven H. Lin, MD
Email:
Principal Investigator
Start date:
January 10, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Nektar Therapeutics
Agency class:
Industry
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05632809
http://www.mdanderson.org
