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Prophylactic Neopeptide Vaccine in Advanced ALK+ NSCLC

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05950139
Collaborator
(none)
12
Enrollment
1
Arm
59
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety of a peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.

Condition or Disease Intervention/Treatment Phase
  • Biological: Peptide vaccine
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of a Prophylactic Neopeptide Vaccine in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) NSCLC
Anticipated Study Start Date :
Aug 1, 2024
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Advanced ALK+ NSCLC

All patients will receive the intervention

Biological: Peptide vaccine
Peptide vaccine

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-related adverse events [Up to 2 years]

    The safety of administering the ALK peptide vaccine will be assessed by the occurrence of the following adverse events: Grade 3 or above drug-related toxicities Drug-related toxicity by grade Vaccine site reactions after vaccine injections Immune-related adverse events (AEs) Unacceptable toxicities Treatment-emergent changes from normal to abnormal values in key laboratory parameters

  2. Vaccine-specific immune response [Up to 2 years]

    Vaccine-specific response will be evaluated by the fold change in interferon-producing mutant-ALK-specific CD8 and CD4 T cells in the peripheral blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)

  2. Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS

  3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months

  4. No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

  6. Males or females at least 18 years old

Exclusion Criteria:

  1. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.

  2. Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine

  3. Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine

  4. Systemic immune suppression:

  5. HIV disease

  6. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)

  7. Other clinically relevant systemic immune suppression

  8. Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted

  9. Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier:
NCT05950139
Other Study ID Numbers:
  • IRB00393510
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 25, 2023