What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as the combination of gemcitabine and nab-paclitaxel, are associated with several side effects. These include neutropenia, fatigue, neuropathy, and diarrhea. Specifically, grade 3 or 4 toxicities for this combination can include neutropenia (up to 49%), fatigue (27%), and neuropathy (20%). Immune checkpoint inhibitors, like those used in combination with futibatinib, can also cause immune-related adverse events such as fatigue, diarrhea, and potential autoimmune reactions. Patients should discuss these potential side effects with their healthcare provider to make an informed treatment decision.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer primarily include chemotherapy regimens such as gemcitabine and nab-paclitaxel. Immune checkpoint inhibitors like pembrolizumab and nivolumab have also been approved for use in certain cancers, but their specific approval for pancreatic cancer is limited. There is no specific mention of FDA-approved treatments combining FGFR inhibitors with PD-1 antibodies for pancreatic cancer in the provided context. Current research, such as the trial involving futibatinib (a selective FGFR inhibitor) in combination with PD-1 antibody-based standard of care therapy, is exploring new potential treatment options.

What other types of research exist?

Promising alternatives to Futibatinib in combination with PD-1 antibody-based SoC therapy for pancreatic cancer patients include the combination of PARP inhibitors like Veliparib with chemotherapy regimens such as FOLFIRI, although it did not improve survival in a specific study, it may still be worth exploring in different contexts. Additionally, the combination of anti-VEGF (FP3) and anti-EGFR (cetuximab) therapies has shown significant improvement in tumor growth inhibition in metastatic colon carcinoma models and may be considered for pancreatic cancer. Further research and clinical trials are warranted to confirm their efficacy in pancreatic cancer.

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Tyrosine Kinase Inhibitor

Futibatinib + PD-1 Antibody for Esophageal Cancer

Phase 2

Recruiting

Research Sponsored by Taiho Oncology, 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 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a new cancer treatment to see if it's safe & effective.

Who is the study for?

Adults over 18 with advanced esophageal cancer that can't be removed by surgery or has spread, and who haven't had previous systemic treatments for it. Participants must have a certain PD-L1 score, good performance status, proper organ function, ability to take oral meds, and no other active cancers or significant health issues like HIV/Hepatitis B/C.

What is being tested?

The trial is testing the combination of Futibatinib with standard-of-care immunotherapy (PD-1 antibody) and chemotherapy drugs in patients with solid tumors. It's an open-label study where everyone gets the treatment to see how effective and safe it is.

What are the potential side effects?

Possible side effects include immune-related reactions due to Pembrolizumab (PD-1 antibody), such as inflammation in organs; typical chemo side effects like nausea, fatigue, hair loss; plus specific risks from Futibatinib related to liver function changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ORR by investigator assessment

Secondary study objectives

6-month PFS rate

DCR per investigator assessment

DoR per investigator assessment

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment7 Interventions

Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) .

Group II: Cohort AExperimental Treatment7 Interventions

Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

2017

Completed Phase 3

~2590

Futibatinib

2014

Completed Phase 2

~410

Pembrolizumab

2017

Completed Phase 3

~2810

Cisplatin

2013

Completed Phase 3

~3120

5-FU

2014

Completed Phase 3

~3100

Oxaliplatin

2011

Completed Phase 4

~2890

Leucovorin

2005

Completed Phase 4

~6010

Levoleucovorin

2019

Completed Phase 2

~20

Do I qualify?Apply below to find out

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

Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as FOLFIRINOX and gemcitabine-based regimens, kills rapidly dividing cancer cells, reducing tumor size and alleviating symptoms. Targeted therapies, like FGFR inhibitors (e.g., futibatinib), focus on specific genetic mutations or pathways crucial for cancer cell survival. Immunotherapy, particularly PD-1/PD-L1 inhibitors, boosts the immune system's ability to attack cancer cells by blocking proteins that inhibit immune responses. These treatments are vital for pancreatic cancer patients as they offer multiple strategies to manage disease progression, improve survival, and enable personalized treatment based on genetic profiles.