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Non Small Cell Lung CancerPhase 2NCT04998474

FRAME-001 Personalized Vaccine in NSCLC

A Phase 2 study testing FRAME-001 personalized vaccine in people with Non Small Cell Lung Cancer, run by Frame Pharmaceuticals B.V. at 3 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Despite encouraging results of programmed cell death protein -1 (PD-1) immune checkpoint inhibitor treatment combined with chemotherapy in advanced non-small cell lung cancer (NSCLC), only the minority of approximately 20% of patients derive durable clinical benefit from such treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
FRAME-001 personalized vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesNetherlands
Study dates
Jan 2022to Jul 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically and radiologically confirmed advanced squamous or non-squamous NSCLC with SD after four cycles of treatment with pembrolizumab as monotherapy or in combination with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel) and suitable for maintenance treatment with pembrolizumab monotherapy.
  • Patient Framome identification and characterization with demonstrated expressed at least three frameshift mutations (Frames) with combined ³100 amino acids (preferably more than 100 amino acids) completed as part of molecular pre-screening.
  • Eastern Cooperative Oncology Group (ECOG) £1.
  • An expected survival of at least 3 months.
  • Presence of tumor lesion(s) suitable for biopsy and radiological assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
  • Written informed consent according to International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).

Who cannot join

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Any active infection that might according to investigator interfere with FRAME-001 vaccination.
  • Current use of systemic corticosteroids (or other immunosuppressive agents; >10mg daily prednisone equivalent). Inhaled, intranasal or topical and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted.
  • Live vaccine within 30 days prior to first dose of FRAME-001.

Trial locations and contacts

3 sites in 1 country.

Bob Löwenberg, MD contact

0202374970

trials@frametherapeutics.com

Wigard Kloosterman, PhD contact

0202374970

trials@frametherapeutics.com

Netherlands3 sites

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

    W.S.M.E. Theelen, MD

    E.F. Smit, MD

  • University Medical Center Groningen

    Groningen, 9713 GZ

    T.J.N. Hiltermann, MD

    H.J.M. Groen, MD

  • Erasmus MC

    Rotterdam, 3015 GD

    J.G.J.V. Aerts, MD

Other trials in Netherlands

About this study

Official title: A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer

Despite encouraging results of programmed cell death protein -1 (PD-1) immune checkpoint inhibitor treatment combined with chemotherapy in advanced non-small cell lung cancer (NSCLC), only the minority of approximately 20% of patients derive durable clinical benefit from such treatment. Patients with stable disease (SD) after four cycles of treatment with PD-1 inhibitor pembrolizumab monotherapy or in combination with chemotherapy (standard of care in advanced NSCLC in the Netherlands) have a low probability of still acquiring a complete response (CR) or durable disease control to such treatment and no other curative standard treatment options are available, emphasizing the need for novel therapeutic approaches. Tumor-specific neopeptides resulting from frameshift mutations in tumor cells, so-called Frames, present potentially potent targets for the immune system and can be utilized in therapeutic anti-cancer vaccination with the intention to synergize in their effect with immune chckpoint inhibitors. Frames are prevalent in NSCLC patients, with 95% of lung tumors harboring one or more Frames. The entire collection of Frames expressed by a tumor is referred to as the Framome. Vaccination against strongly antigenic neopeptides present in a patient's tumor furnishes a perspective of enhancing the therapeutic effect of the immune checkpoint inhibition in NSCLC with expected limited additional toxicities. The current clinical trial is designed to determine immune response, safety, and clinical response of personalized vaccine FRAME-001 based on a patient's Framome and selection of Frame peptides in advanced NSCLC cancer patients after standard first line treatment consisting of immune checkpoint inhibitor pembrolizumab as monotherapy or combined with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel), and who attained SD after four cycles of such therapy. The personalized FRAME-001 vaccine will be administered during maintenance phase of treatment with pembrolizumab monotherapy.

Being tested
FRAME-001 personalized vaccine
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FRAME-001 personalized vaccineBiological

    Patients will receive personalized peptide vaccine FRAME-001 based on frame-shift mutations (Frames) detected by Whole Genome Sequencing (WGS)/Ribonucleic Acid sequencing (RNAseq) in a tumor biopsy. FRAME-001 vaccine will be administered in four sequential cycles at 3-week interval (Q3W), along standard maintenance monotherapy of pembrolizumab (administration Q3W or Q6W). Each cycle will be consisting of up to four subcutaneous injections at up to four different sites in the upper and lower limbs.

Study groups in NCT04998474
Study groupRoleWhat they receive
FRAME-001 personalized vaccineExperimentalProspective, single arm, multi center, open-label, phase II clinical trial. Patients will receive personalized peptide vaccine FRAME-001 based on frame-shift mutations (Frames) detected by Whole Genome Sequencing (WGS)/Ribonucleic Acid sequencing (RNAseq) in a tumor biopsy. FRAME-001 vaccine will be administered in four sequential cycles at 3-week interval (Q3W), along standard maintenance monotherapy of pembrolizumab (administration Q3W or Q6W). Each cycle will be consisting of up to four subcutaneous injections at up to four different sites in the upper and lower limbs.
Receives: Biological: FRAME-001 personalized vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FRAME-001-specific immune responses in peripheral blood after administration of FRAME-001

    Antigen-specific immune responses in peripheral blood to one or more Frame peptides following application of a personalized FRAME-001 vaccine, based on a positive outcome in one or more of the following assays:

    1. 4-Day interferon gamma (IFNg) enzyme-linked immunospot (ELISpot) assay.
    2. IFNg, tumor necrosis factor alpha (TNFa), and/or interleukin-2 (IL-2) producing CD4+ and/or CD8+ T cells determined in intracellular cytokine staining assay.
    3. Specific cytokine production as measured by Th1/Th2 cytokine bead array in culture supernatants.

    Measured: Week 7, 10, 13, 16, 19 and week 49

Secondary outcomes (2)

  1. The number of adverse events (AEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Assessment of safety and tolerability of FRAME-001

    Measured: Up to week 22

  2. Evaluation of clinical anti-tumor response and survival after treatment with FRAME-001

    Tumor response and tumor response duration according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria. And progression-free survival (PFS) and overall survival (OS).

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study startJan 2022 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998474
Sponsor's protocol ID
FRAME-001
Status last verified
Aug 2021
First submitted
1 Jul 2021
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FRAME-001 personalized vaccine in people with Non Small Cell Lung Cancer, run by Frame Pharmaceuticals B.V. at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bob Löwenberg, MD (0202374970, trials@frametherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FRAME-001-specific immune responses in peripheral blood after administration of FRAME-001 (time frame: Week 7, 10, 13, 16, 19 and week 49). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04998474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.

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