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Solid TumorsPhase 1NCT02301754

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy

A Phase 1 study testing INVAC-1 in people with Solid Tumors, run by Invectys at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
INVAC-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesFrance
Study dates
Nov 2014to 1 Jun 2018
Phase
Phase 1
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

  • Histological diagnosis of advanced/metastatic solid tumor malignancy
  • Relapsed or refractory to standard treatment and for whom standard curative options do not exist
  • Life-expectancy > 4 months
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • A delay of at least 3 weeks between last specific anticancer treatment and first INVAC-1 injection
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  • Adequate skin status
  • Lack of biologically documented inflammation: C Reactive Protein < 15 mg/L
  • No medical history of auto-immune disease
  • Adequate bone marrow function
  • Total white cells count ≤ 10 x 109/L (≤ 10,000/µL),
  • Serum albuminemia > 30 g/L
  • Adequate renal function, with an estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockroft \& Gault method
  • Adequate liver function
  • Adequate cardiac function
  • Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 CTCAE v. 4.03 except for Adverse Events not constituting a safety risk by investigator judgment
  • Lack of immune-suppressive drugs and of high-dose corticoid treatment within 8 weeks prior to entering the study (prednisone or prednisolone ≤ 10 mg/day is allowed)
  • Serum pregnancy test (for females of childbearing potential) negative within 7 days of first dose of study drug
  • Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator.
  • Provision of written informed consent indicating that the patient has been informed of all the pertinent aspects of the trial to be followed
  • Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Who cannot join

  • Central Nervous System (CNS) primary or CNS metastatic malignancies
  • Prior allogeneic hematopoietic stem cell transplant
  • Chemotherapy, cancer immunosuppressive therapy, growth factors, systemic steroids, or investigational agents within 28 days before the first dose of study treatment
  • Prior therapy with a compound of the same mechanism (immunomodulation) in the last 90 days prior to first dose of study drug
  • Participation to a clinical trial of an experimental medication in the last 30 days prior to first dose of study drug
  • Major surgery within 28 days of starting study treatment
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  • Radiation therapy within 28 days of starting study treatment
  • Autoimmune disorders (eg, Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system.
  • Contra-indications to electroporation: cardiac pacemaker, any previous cardiac rhythm disorder, epilepsy.
  • Active and clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (HIV testing is not required).
  • Unstable or serious concurrent medical conditions in the previous 12 months.
  • Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Patients who are pregnant or breastfeeding.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
  • Patients who are investigational site staff members or patients who are Invectys employees directly involved in the conduct of the trial.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Européen Georges Pompidou

    Paris, 75015

Other trials in France

About this study

Official title: A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer

INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.

Read the detailed description

This is the first-in-patient study of INVAC-1, a DNA vaccine encoding human telomerase reverse transcriptase (hTERT). hTERT is the catalytic subunit of the telomerase complex which synthesizes telomeric DNA at the chromosome ends. hTERT is overexpressed in most human tumors and virtually all types of cancers.

INVAC-1 is developed for cancer therapy. Stimulation of the immune system directed against telomerase expressing cancer cells has the potential to generate tumor responses.

The study is designed to evaluate the safety and pharmacodynamics (PD) of INVAC-1 administered alone by intradermal route to adults with solid tumor malignancies.

As shown in non-clinical studies, the efficacy of the vaccine is enhanced by electroporation, which thus will be combined with the vaccination in the present study.

The general clinical plan includes development of INVAC-1 in both hematologic malignancies and solid tumors, as a single agent and in combination with other targeted anticancer agents such as check-points inhibitors, radiotherapy or chemotherapies.

Conditions
Solid Tumors
Being tested
INVAC-1

What participants receive

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

  • INVAC-1Biological

    intradermal injection combined with electroporation

Study groups in NCT02301754
Study groupRoleWhat they receive
INVAC-1ExperimentalINVAC-1 at escalating doses of 100, 400 and 800 µg will be given as a single agent by intradermal injection (Q 4 weeks x 3 cycles), always combined with electroporation. Each patient will receive 3 cycles, unless motivated treatment interruption.
Receives: Biological: INVAC-1

What is being measured

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

  1. Dose Limiting Toxicities (DLTs) of INVAC-1 as single agent in combination with electroporation

    Measured: up to 28 days after last injection

Secondary outcomes (11)

  1. Adverse Events as characterized by type, frequency, severity (as graded by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.03), timing, seriousness and relationship to study therapy INVAC-1 + electroporation;

    Measured: up to 28 days after last injection

  2. Routine laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing

    Measured: up to 28 days after last injection

  3. Tumor Necrosis Factor-α, Interleukine (IL)-17, IL-8, IL-6, IL-1β measured in serum

    Measured: up to 28 days after last injection

  4. anti-nuclear antibodies (ANA), anti-DNA, anti-TPO measured in serum

    Measured: up to 28 days after last injection

  5. Elispot Interferon gamma

    Measured: every 4 weeks up to 3 months

  6. Absolute cell counts and phenotype for circulating T and Natural Killer cells

    Measured: every 2 weeks up to 3 months

  7. circulating tumor DNA assessed by quantification of the allelic fraction of the DNA mutations; circulating DNA is extracted from plasma

    Measured: before treatment; at day 15 of cycle 3

  8. Objective response assessed by immune-related Response Criteria (ir-RC);

    Measured: every 8 weeks during treatement and every 2 to 4 months during one-year follow-up

  9. Duration of response

    Measured: every 8 weeks during treatement and every 2 to 4 months during one-year follow-up

  10. Progression free survival

    Measured: approximately 15 months

  11. Overall survival

    Measured: approximately 15 months

Timeline

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

  1. First posted26 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionFeb 2018
  4. Study completion1 Jun 2018

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02301754
Sponsor's protocol ID
INVAC1-CT-101
Status last verified
Feb 2019
First submitted
18 Nov 2014
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Teixeira L, Medioni J, Garibal J, Adotevi O, Doucet L, Durey MD, Ghrieb Z, Kiladjian JJ, Brizard M, Laheurte C, Wehbe M, Pliquet E, Escande M, Defrance R, Culine S, Oudard S, Wain-Hobson S, Doppler V, Huet T, Langlade-Demoyen P. A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Feb 1;26(3):588-597. doi: 10.1158/1078-0432.CCR-19-1614. Epub 2019 Sep 26.

    PubMed 31558479

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INVAC-1 in people with Solid Tumors, run by Invectys at 2 sites in France.

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 21 inclusion and 15 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: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) of INVAC-1 as single agent in combination with electroporation (time frame: up to 28 days after last injection). 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 NCT02301754, which also lists 1 linked publication.

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 26 Feb 2019.

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