Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

NSCLC Stage IV Clinical Trial

Official title:

Pilot Study of a Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950139
• Other study ID #: J23120
• Secondary ID: IRB00398546
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 2024
• Est. completion date: July 2029

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Joanne Riemer, RN
• Phone: 443-287-4114
• Email: ThoracicCancerTrials[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2029
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK Fusion Protein Expression
• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IV

Intervention

Biological:
• Peptide vaccine
Peptide vaccine

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events	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	Up to 2 years
Primary	Vaccine-specific immune response	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.	Up to 2 years