The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05950139
Recruitment Status : Recruiting
First Posted : July 18, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the safety of a cancer 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
NSCLC Stage IV ALK Fusion Protein Expression Biological: Peptide vaccine Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 Peptide Vaccine in Advanced ALK+ NSCLC
Estimated Study Start Date : August 2024
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Advanced ALK+ NSCLC
All patients will receive the intervention
 Biological: Peptide vaccine
Peptide vaccine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
    2. Other clinically relevant systemic immune suppression
  5. 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
  6. 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05950139


Contacts
Layout table for location contacts
Contact: Joanne Riemer, RN 443-287-4114 ThoracicCancerTrials@jhmi.edu
Contact: Peggy Fitzpatrick, RN 410-550-5848 mfitzpa7@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Joanne Riemer, RN    443-287-4114      
Contact: Peggy Fitzpatrick, RN    410-550-5848      
Principal Investigator: Vincent Lam, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Layout table for investigator information
Principal Investigator: Vincent Lam, MD Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT05950139    
Other Study ID Numbers: J23120
IRB00398546 ( Other Identifier: Johns Hopkins IRB )
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024

Layout table for additional information
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:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases