CancerPhase 1/2ICONICNCT02904226
JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors
A Phase 1/2 study testing JTX-2011, Nivolumab and Ipilimumab in people with Cancer, run by Jounce Therapeutics, Inc. at 16 sites in United States.
Trial summary
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- JTX-2011, Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2016to 1 Jul 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
- Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, and meet the requirements for the intended study cohort
- Male or Female ≥ 18 years of age
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if approved by Medical Monitor
- Have a predicted life expectancy of ≥ 3 months
- Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol
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- If medical history of the following, case should be reviewed by the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders
- Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011
- WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Who cannot join
- Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
- Have refused standard therapy
- Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.
- Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;
- Have received CAR-T therapy;
- Have received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or nitrosoureas;
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- Have received targeted small molecule therapy < 14 days prior to C1D1;
- Have undergone organ transplantation including allogeneic or autologous stem-cell transplantation, at any time;
- Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1
- Have a history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune adverse events on prior immunotherapy, or documented presence of neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects who discontinued prior immunotherapies for immune-related adverse events that are well-controlled with appropriate treatment may be enrolled if approved by the Medical Monitor.
- Have a diagnosis of immunodeficiency, either primary or acquired, or treatment with systemic steroids or any other form of immunosuppressive therapy within 7 days prior to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease as well as a one-time dose of immunosuppressive agents used prophylactically for contrast allergies
- Have any active disease requiring systemic immunosuppressive treatment
- Have known severe intolerance to or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous immunoglobulin preparations; any history of anaphylaxis; prior history of human anti-human antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic, either treated or untreated, will be allowed)
- Have current second malignancy at other sites, which requires treatment, or in the judgement of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. A past history of other malignancies is allowed as long as the subject is not receiving specific treatment other than hormonal therapy, and, in the judgement of the Investigator, is unlikely to have a recurrence.
- Have active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
- Have received live vaccines within past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to first infusion day)
- Women who are pregnant or breastfeeding
- Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management
- Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Sarah Cannon Research Institute at TriStar Health
Nashville, Tennessee, 37203
Yale New Haven Hospital
New Haven, Connecticut, 06510
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford University School of Medicine
Palo Alto, California, 94304
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Read the detailed description
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.
- Conditions
- Cancer
- Being tested
- JTX-2011, Nivolumab, Ipilimumab, Pembrolizumab
- Keywords
- ICOS, ICOS agonist monoclonal antibody, JTX-2011, Anti-PD-1, Nivolumab, ICONIC, Immunotherapy, Immuno-oncology, Cancer, Solid Tumor, Dose Escalation, Dose Expansion, Anti-CTLA-4, Ipilimumab, Pembrolizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTX-2011Drug
Also called ICOS agonist monoclonal antibody
Specified dose on specified days
NivolumabDrug
Also called Opdivo
Specified dose on specified days
IpilimumabDrug
Also called Yervoy
Specified dose on specified days
PembrolizumabDrug
Also called Keytruda
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A (JTX-2011) | Experimental | Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion Receives: Drug: JTX-2011 |
| Part B (JTX-2011 + nivolumab) | Experimental | Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion Receives: Drug: JTX-2011; Drug: Nivolumab |
| Part C (JTX-2011) | Experimental | Phase 2 expansion of JTX-2011 by IV infusion Receives: Drug: JTX-2011 |
| Part D (JTX-2011 + nivolumab) | Experimental | Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion Receives: Drug: JTX-2011; Drug: Nivolumab |
| Part E (JTX-2011 + ipilimumab) | Experimental | Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion Receives: Drug: JTX-2011; Drug: Ipilimumab |
| Part F (JTX-2011 + ipilimumab) | Experimental | Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion Receives: Drug: JTX-2011; Drug: Ipilimumab |
| Part G (JTX-2011 + pembrolizumab) | Experimental | Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion Receives: Drug: JTX-2011; Drug: Pembrolizumab |
| Part H (JTX-2011 + pembrolizumab) | Experimental | Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion Receives: Drug: JTX-2011; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Measured: 46.3 months
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: 46.3 months
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: 46.3 months
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
Measured: 46.3 months
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Measured: 46.3 months
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Measured: 46.3 months
Number of Participants With Dose Limiting Toxicities
Number of participants with at least one dose limiting toxicity (DLT)
Measured: 33 months
Overall Response Rate
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Measured: 46.5 months
Disease Control Rate
Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Measured: 46.5 months
Progression Free Survival
Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Measured: 46.5 months
6 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Measured: 46.5 months
12 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Measured: 46.5 months
Landmark Overall Survival at 6 Months
Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Measured: 46.5 months
Landmark Overall Survival at 12 Months
Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Measured: 46.5 months
Overall Survival
The time from first dose date to the date of death for any cause
Measured: 46.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jounce Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stew Kroll, Study director, Jounce Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904226
- Sponsor's protocol ID
- JTX-2011-101
- Acronym
- ICONIC
- Status last verified
- Jun 2023
- First submitted
- 7 Sep 2016
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT02904226
- Acronym / sponsor ID
- ICONIC / JTX-2011-101
- Conditions
- Cancer
- Keywords
- ICOS, ICOS agonist monoclonal antibody, JTX-2011, Anti-PD-1, Nivolumab, ICONIC, Immunotherapy, Immuno-oncology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Jounce Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Detailed description
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A (JTX-2011) | Experimental | Drug: JTX-2011Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion |
| Part B (JTX-2011 + nivolumab) | Experimental | Drug: JTX-2011, Drug: NivolumabPhase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion |
| Part C (JTX-2011) | Experimental | Drug: JTX-2011Phase 2 expansion of JTX-2011 by IV infusion |
| Part D (JTX-2011 + nivolumab) | Experimental | Drug: JTX-2011, Drug: NivolumabPhase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion |
| Part E (JTX-2011 + ipilimumab) | Experimental | Drug: JTX-2011, Drug: IpilimumabPhase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion |
| Part F (JTX-2011 + ipilimumab) | Experimental | Drug: JTX-2011, Drug: IpilimumabPhase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion |
| Part G (JTX-2011 + pembrolizumab) | Experimental | Drug: JTX-2011, Drug: PembrolizumabPhase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion |
| Part H (JTX-2011 + pembrolizumab) | Experimental | Drug: JTX-2011, Drug: PembrolizumabPhase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
- Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, and meet the requirements for the intended study cohort
- Male or Female ≥ 18 years of age
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if approved by Medical Monitor
- Have a predicted life expectancy of ≥ 3 months
Key exclusion criteria (20 listed)
- Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
- Have refused standard therapy
- Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.
- Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1
- Have a history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune adverse events on prior immunotherapy, or documented presence of neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects who discontinued prior immunotherapies for immune-related adverse events that are well-controlled with appropriate treatment may be enrolled if approved by the Medical Monitor.
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 |
|---|---|---|
| JTX-2011Also: ICOS agonist monoclonal antibodySpecified dose on specified days | Drug | Part A (JTX-2011), Part B (JTX-2011 + nivolumab), Part C (JTX-2011), Part D (JTX-2011 + nivolumab), Part E (JTX-2011 + ipilimumab), Part F (JTX-2011 + ipilimumab), Part G (JTX-2011 + pembrolizumab), Part H (JTX-2011 + pembrolizumab) |
| NivolumabAlso: OpdivoSpecified dose on specified days | Drug | Part B (JTX-2011 + nivolumab), Part D (JTX-2011 + nivolumab) |
| IpilimumabAlso: YervoySpecified dose on specified days | Drug | Part E (JTX-2011 + ipilimumab), Part F (JTX-2011 + ipilimumab) |
| PembrolizumabAlso: KeytrudaSpecified dose on specified days | Drug | Part G (JTX-2011 + pembrolizumab), Part H (JTX-2011 + pembrolizumab) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time frame: 46.3 months
Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Time frame: 46.3 months
Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Time frame: 46.3 months
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Time frame: 46.3 months
Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Time frame: 46.3 months
Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Time frame: 46.3 months
Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Number of Participants With Dose Limiting Toxicities
Time frame: 33 months
Number of participants with at least one dose limiting toxicity (DLT)
Overall Response Rate
Time frame: 46.5 months
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Disease Control Rate
Time frame: 46.5 months
Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Progression Free Survival
Time frame: 46.5 months
Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
6 Month Landmark Progression Free Survival
Time frame: 46.5 months
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
12 Month Landmark Progression Free Survival
Time frame: 46.5 months
Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Landmark Overall Survival at 6 Months
Time frame: 46.5 months
Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Landmark Overall Survival at 12 Months
Time frame: 46.5 months
Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Overall Survival
Time frame: 46.5 months
The time from first dose date to the date of death for any cause
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stew Kroll study director
Jounce Therapeutics, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JTX-2011, Nivolumab and Ipilimumab in people with Cancer, run by Jounce Therapeutics, Inc. at 16 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 9 inclusion and 20 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Treatment Emergent Adverse Events (TEAE) (time frame: 46.3 months). The study lists 15 primary outcomes in all. 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 3 Jul 2023.