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Cervical CancerPhase 1NCT03538028

A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

A Phase 1 study testing INCAGN02385 in people with Cervical Cancer and Microsatellite Instability (MSI)-High Endometrial Cancer, run by Incyte Biosciences International Sàrl at 4 sites in United States.

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

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INCAGN02385
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
4 sitesUnited States
Study dates
18 Jun 2018to 7 Oct 2020
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

  • Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
  • Disease progression after treatment with available therapies that are known to confer clinical benefit, or intolerant to treatment, or refuse noncurative standard treatment. There is no limit to the number of prior treatment regimens.
  • Participants with advanced or metastatic cervical cancer, MSI-high endometrial cancer, gastric cancer (including stomach and GEJ), esophageal cancer, hepatocellular carcinoma, melanoma (uveal melanoma excluded), Merkel cell carcinoma, mesothelioma, MSI-high colorectal cancer, NSCLC, ovarian cancer, SCCHN, SCLC, RCC, triple-negative breast cancer, and urothelial carcinoma, or alternative immunogenic tumor types with medical monitor approval. Participants with DLBCL may participate in Part 2 of the study.
  • Presence of measureable disease based on RECIST v1.1 for solid tumors or the Lugano classification for DLBCL.
  • Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies.
  • Eastern Cooperative Oncology Group performance status 0 or 1.

Who cannot join

  • Laboratory and medical history parameters outside the protocol-defined range.
  • Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before study Day 1.
  • Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
  • Receipt of a live vaccine within 30 days of planned start of study drug.
  • Active autoimmune disease that required systemic treatment in the past.
  • Known active CNS metastases and/or carcinomatous meningitis.
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  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. See protocol-defined exceptions.
  • Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
  • Active infection requiring systemic therapy.
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
  • Known history of HIV (HIV 1/2 antibodies).
  • Prior treatment with an anti-LAG-3 antibody for any indication.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • The Angeles Clinic and Research Center

    Los Angeles, California, 90025

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.

Being tested
INCAGN02385
Keywords
lymphocyte activation gene (LAG), LAG-3, advanced solid tumor, metastatic solid tumor, relapsed/refractory DLCBL
Medical subject headings
Uterine Cervical Neoplasms, Microsatellite Instability, Stomach Neoplasms, Esophageal Neoplasms, Carcinoma, Hepatocellular, Melanoma, Carcinoma, Merkel Cell, Mesothelioma

What participants receive

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

  • INCAGN02385Biological

    INCAGN02385 administered as an intravenous infusion over 30 minutes.

Study groups in NCT03538028
Study groupRoleWhat they receive
INCAGN02385ExperimentalPart 1: INCAGN02385 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or pharmacologically active dose. Part 2: INCAGN02385 administered Q2W or Q4W at the recommended dose(s) from Part 1.
Receives: Biological: INCAGN02385

What is being measured

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

  1. Number of treatment-emergent adverse events (TEAEs)

    TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Measured: Up to 12 months

Secondary outcomes (11)

  1. Cmax of INCAGN02385

    Maximum observed plasma concentration.

    Measured: Up to 12 months

  2. Tmax of INCAGN02385

    Time to maximum plasma concentration.

    Measured: Up to 12 months

  3. Cmin of INCAGN02385

    Minimum observed plasma concentration during the dosing interval.

    Measured: Up to 12 months

  4. AUC0-t of INCAGN02385

    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.

    Measured: Up to 12 months

  5. Objective response rate (ORR) in participants with advanced or metastatic solid tumors

    Defined as the percentage of participants having complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to 12 months

  6. Disease control rate (DCR) in participants with advanced or metastatic solid tumors

    Defined as percentage of participants having CR, PR, or stable disease (SD) as best on-study response.

    Measured: Up to 12 months

  7. Duration of response (DOR) in participants with advanced or metastatic solid tumors

    Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression per RECIST v1.1 or death from any cause, if occurring sooner than progression.

    Measured: Up to 12 months

  8. Progression-free survival (PFS) in participants with advanced or metastatic solid tumors

    Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1 or death from any cause if occurring sooner than progression.

    Measured: Up to 12 months

  9. ORR in participants with diffuse large B-cell lymphoma (DLBCL)

    Defined as the percentage of participants with a CR/complete metabolic response (CMR) or PR/partial metabolic response (PMR) per the Lugano Classification.

    Measured: Up to 12 months

  10. DOR in participants with DLBCL

    Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression per radiographic disease assessment or death from any cause among participants who achieve an objective response.

    Measured: Up to 12 months

  11. PFS in participants with DLBCL

    Defined as the time from the date of the first dose of study drug until the earliest date of disease progression per radiographic disease assessment or death from any cause if occurring sooner than progression.

    Measured: Up to 12 months

Timeline

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

  1. First posted25 May 2018
  2. Study start18 Jun 2018
  3. Primary completion7 Oct 2020
  4. Study completion7 Oct 2020

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03538028
Sponsor's protocol ID
INCAGN 2385-101
Status last verified
Oct 2020
First submitted
15 May 2018
Last updated
30 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCAGN02385 in people with Cervical Cancer and Microsatellite Instability (MSI)-High Endometrial Cancer, run by Incyte Biosciences International Sàrl at 4 sites in United States.

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 12 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 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Number of treatment-emergent adverse events (TEAEs) (time frame: Up to 12 months). 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 NCT03538028.

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 30 Oct 2020.

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