What side effects are associated with this type of intervention?

Common side effects of immunotherapy treatments, such as immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab, ipilimumab), include skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), endocrine disorders (thyroid dysfunction, adrenal insufficiency), and respiratory complications (pneumonitis). These treatments can also cause fatigue, musculoskeletal pain, and, less frequently, severe adverse events like hepatic toxicity, acute renal failure, and sepsis. Management of these side effects often involves corticosteroids and other immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several immunotherapies that enhance the immune response against cancer cells. Notable approvals include pembrolizumab and nivolumab, both PD-1 inhibitors, which have been approved for various cancers such as melanoma, non-small cell lung cancer, and more. Additionally, ipilimumab, a CTLA-4 inhibitor, has been approved for melanoma. Avelumab, a PD-L1 inhibitor, is approved for Merkel cell carcinoma. These therapies work by blocking inhibitory pathways in T cells, thereby enhancing the immune system's ability to attack cancer cells.

What other types of research exist?

Promising novel alternatives to JTX-8064 for cancer patients in 2024 include: 1) Pembrolizumab (PD-1 inhibitor) combined with other agents like talimogene laherparepvec (T-VEC) for advanced melanoma. 2) Cabozantinib, a tyrosine kinase inhibitor, showing activity in various cancers including medullary thyroid cancer and non-small cell lung cancer. 3) Mifamurtide in conjunction with methotrexate, doxorubicin, and cisplatin for osteosarcoma. 4) Elotuzumab combined with lenalidomide and dexamethasone for multiple myeloma. These alternatives are based on their potential to enhance immune response and their ongoing evaluation in clinical trials.

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Monoclonal Antibodies

JTX-8064 + PD-1 Inhibitor for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Jounce Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests JTX-8064, a protein that helps the immune system attack cancer, in adults with advanced cancers that don't respond to standard treatments. It works by stopping cancer cells from hiding from the immune system.

Who is the study for?

Adults with advanced solid tumors that have not responded to standard treatments, including those who've progressed after chemotherapy and immunotherapy. Specific conditions like biliary tract cancer, kidney cancer, head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), cutaneous squamous cell carcinoma (cSCC), uterine sarcomas, and triple-negative breast cancer are included at different stages. Participants must be over 18 years old with a life expectancy of more than 3 months and meet certain health criteria.

What is being tested?

The trial is testing JTX-8064 alone or combined with a PD-1 inhibitor in patients whose cancers haven't improved with other treatments. It's an early-phase study to find the safest dose for future research. Patients will receive these drugs through infusions and their effects will be closely monitored.

What are the potential side effects?

Possible side effects include typical reactions related to immune therapies such as fatigue, skin reactions, inflammation in various organs which can cause symptoms like cough or diarrhea depending on the organ affected; infusion-related reactions; potential changes in blood tests indicating liver or kidney function issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups

Experimental Treatment

Group I: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced clear cell renal cell carcinoma (ccRCC).

Group II: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced cutaneous squamous cell carcinoma (cSCC).

Group III: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS).

Group IV: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced triple negative breast cancer (TNBC).

Group V: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with PD-(L)1i-experienced HNSCC.

Group VI: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, platinum-resistant ovarian cancer.

Group VII: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced non-small cell lung cancer (NSCLC).

Group VIII: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, PD-L1+ head and neck squamous cell carcinoma (HNSCC).

Group IX: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with biliary tract cancer (BTC), including intra-and extra-hepatic biliary duct cancer and cancer of the gallbladder. All subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting, must have PD-(L)1i resistance.

Group X: Stage 3 Expansion: JTX-8064 monotherapy (Ovarian)Experimental Treatment1 Intervention

Cohort will enroll subjects with advanced/metastatic PD-1/PD-L1 (PD-(L)1)-naïve, platinum-resistant ovarian cancer.

Group XI: Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimabExperimental Treatment2 Interventions

Dose Escalation, Stage 2: JTX-8064 in combination with pimivalimab. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies.

Group XII: Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalationExperimental Treatment1 Intervention

Dose Escalation, Stage 1: JTX-8064 Monotherapy. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JTX-8064

2021

Completed Phase 2

~190

pimivalimab

2021

Completed Phase 2

~190

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapy, including treatments like JTX-8064, works by modulating the immune system to recognize and attack cancer cells more effectively. These therapies often target immune checkpoints, such as PD-1/PD-L1, which cancer cells exploit to evade immune detection. By inhibiting these checkpoints, immunotherapy can enhance the body's natural immune response against tumors. This approach is crucial for cancer patients as it offers a targeted treatment option that can potentially lead to longer-lasting remissions and fewer side effects compared to traditional therapies like chemotherapy and radiation.