REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NKTR-255 combination (Durvalumab) 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 |
Drug: NKTR-255
Given by IV (vein)
Drug: Durvalumab
Given by IV (vein)
|
Outcome Measures
Primary Outcome Measures
- Overall survival time distribution [through study completion; an average of 1 year]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- Nektar Therapeutics
Investigators
- Principal Investigator: Steven Lin, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2021-0925
- NCI-2022-09970