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.
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
- Conditions the study is for
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])
- 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.
Show all 12Show fewer
- 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
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.
- Conditions
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer, Hepatocellular Carcinoma, Melanoma (Uveal Melanoma Excluded)
- 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 group | Role | What they receive |
|---|---|---|
| INCAGN02385 | Experimental | Part 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.
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)
Cmax of INCAGN02385
Maximum observed plasma concentration.
Measured: Up to 12 months
Tmax of INCAGN02385
Time to maximum plasma concentration.
Measured: Up to 12 months
Cmin of INCAGN02385
Minimum observed plasma concentration during the dosing interval.
Measured: Up to 12 months
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
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
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
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
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
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
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
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.
- First posted25 May 2018
- Study start18 Jun 2018
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Janik, MD, Study director, Incyte Corporation
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03538028
- Acronym / sponsor ID
- INCAGN 2385-101
- Conditions
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer, Hepatocellular Carcinoma, Melanoma (Uveal Melanoma Excluded)
- Keywords
- lymphocyte activation gene (LAG), LAG-3, advanced solid tumor, metastatic solid tumor, relapsed/refractory DLCBL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Incyte Biosciences International SàrlIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCAGN02385 | Experimental | Biological: INCAGN02385Part 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCAGN02385INCAGN02385 administered as an intravenous infusion over 30 minutes. | Biological | INCAGN02385 |
Primary outcome
Number of treatment-emergent adverse events (TEAEs)
Time frame: Up to 12 months
TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
11 secondary outcomes
Cmax of INCAGN02385
Time frame: Up to 12 months
Tmax of INCAGN02385
Time frame: Up to 12 months
Cmin of INCAGN02385
Time frame: Up to 12 months
AUC0-t of INCAGN02385
Time frame: Up to 12 months
Objective response rate (ORR) in participants with advanced or metastatic solid tumors
Time frame: Up to 12 months
Disease control rate (DCR) in participants with advanced or metastatic solid tumors
Time frame: Up to 12 months
Duration of response (DOR) in participants with advanced or metastatic solid tumors
Time frame: Up to 12 months
Progression-free survival (PFS) in participants with advanced or metastatic solid tumors
Time frame: Up to 12 months
ORR in participants with diffuse large B-cell lymphoma (DLBCL)
Time frame: Up to 12 months
DOR in participants with DLBCL
Time frame: Up to 12 months
PFS in participants with DLBCL
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Janik, MD study director
Incyte Corporation
4 sites in 1 country: see every site and its status.
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?
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.