24 Participants Needed

Pembrolizumab + Chemotherapy for Bile Duct Cancer

HT
Overseen ByHop Tran Cao, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after surgery, compared to treatment with surgery and standard chemotherapy alone.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like systemic steroids or immunosuppressive therapy, you may need to adjust them before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination of Pembrolizumab, Gemcitabine, and Cisplatin for bile duct cancer?

Research shows that adding Pembrolizumab, an immune system-boosting drug, to the standard chemotherapy drugs Gemcitabine and Cisplatin may improve outcomes for patients with advanced bile duct cancer, which typically has a poor prognosis.12345

Is the combination of Pembrolizumab, Gemcitabine, and Cisplatin safe for treating bile duct cancer?

In a study of patients with bile duct cancer who were treated with Pembrolizumab after Gemcitabine and Cisplatin, 58.8% experienced treatment-related side effects, but only 7.8% had severe side effects. This suggests that the treatment has manageable safety risks.34678

What makes the drug pembrolizumab combined with chemotherapy unique for bile duct cancer?

This treatment is unique because it combines pembrolizumab, an immune system-boosting drug, with standard chemotherapy drugs gemcitabine and cisplatin, aiming to improve outcomes for bile duct cancer patients by enhancing the body's immune response against the cancer.367910

Research Team

HT

Hop Tran Cao, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults diagnosed with intrahepatic cholangiocarcinoma that can potentially be removed by surgery. They should not have had previous systemic therapy for this cancer, no other active cancers or serious illnesses, and must agree to use contraception. HIV-positive patients on effective treatment can join.

Inclusion Criteria

Adequate hematologic status: ANC ≥ 1.5 x 10^9/L; Hgb ≥ 9 g/dL; PLT ≥ 100 x 10^9/L
HCV viral load undetectable at screening
Willing and able to participate in the trial and comply with all trial requirements
See 10 more

Exclusion Criteria

I do not have any uncontrolled illnesses like heart failure or recent heart attacks.
I have been treated with drugs targeting immune checkpoints.
I have received systemic therapy for bile duct cancer.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab with gemcitabine and cisplatin for 4 cycles (21 days each) before and after surgery

9 months
Clinic visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 years
Clinic visits every 3 months

Treatment Details

Interventions

  • Cisplatin
  • Gemcitabine
  • Pembrolizumab
Trial OverviewThe trial is testing if adding pembrolizumab (an immunotherapy drug) to the usual chemotherapy drugs gemcitabine and cisplatin before and after surgery can improve outcomes in bile duct cancer compared to just surgery and chemotherapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with Gemcitabine and CisplatinExperimental Treatment3 Interventions
Participants will receive 4 cycles (21 days each) of the combined chemotherapy before and after your scheduled surgery. During the 9 months of chemotherapy treatment, participants will have clinic visits every 3 weeks or so. During the 2-4 year follow-up period, participants will come to the clinic every 3 months or so

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇺🇸
Approved in United States as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇨🇦
Approved in Canada as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
🇯🇵
Approved in Japan as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

In a study of 42 patients with inoperable or metastatic cholangiocarcinoma, the combination of gemcitabine and cisplatin showed a response rate of 21%, with a median survival of 10.8 months and a progression-free survival of 8.5 months.
The treatment was generally well-tolerated, with no treatment-related deaths and only mild non-hematologic toxicities, although 33% of patients experienced grade 3-4 anemia.
Experience with gemcitabine and cisplatin in the therapy of inoperable and metastatic cholangiocarcinoma.Charoentum, C., Thongprasert, S., Chewaskulyong, B., et al.[2022]
In a phase 2 trial involving 150 patients with advanced biliary cancers, the addition of cetuximab to standard chemotherapy (gemcitabine and oxaliplatin) did not significantly improve progression-free survival compared to chemotherapy alone, with median progression-free survival of 6.1 months versus 5.5 months, respectively.
While cetuximab was well tolerated, the study found a higher incidence of grade 3-4 adverse events in the cetuximab group, suggesting that the standard chemotherapy regimen should remain the preferred treatment for advanced biliary cancer.
Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial.Malka, D., Cervera, P., Foulon, S., et al.[2022]
In a phase 3 trial involving 1069 patients with advanced biliary tract cancer, the addition of pembrolizumab to the standard chemotherapy regimen of gemcitabine and cisplatin significantly improved median overall survival from 10.9 months to 12.7 months.
The combination treatment did not introduce new safety concerns, with similar rates of severe adverse events between the pembrolizumab and placebo groups, suggesting it could be a viable new option for patients with this challenging cancer.
Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial.Kelley, RK., Ueno, M., Yoo, C., et al.[2023]

References

Experience with gemcitabine and cisplatin in the therapy of inoperable and metastatic cholangiocarcinoma. [2022]
Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. [2022]
Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]
[GEM plus CDDP Combination Therapy for Unresectable Biliary Tract Cancer-A Single Institution Experience]. [2023]
Feasibility and efficacy of gemcitabine plus cisplatin combination therapy after curative resection for biliary tract cancer. [2022]
Efficacy and Safety of Pembrolizumab for Gemcitabine/Cisplatin-Refractory Biliary Tract Cancer: A Multicenter Retrospective Study. [2020]
Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data. [2023]
Phase II study of gemcitabine and cisplatin as first-line chemotherapy in inoperable biliary tract carcinoma. [2022]
Efficacy of pembrolizumab in microsatellite instability-high locally advanced cholangiocarcinoma: a case report. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Multicenter randomized phase II trial of atezolizumab with or without cobimetinib in biliary tract cancers. [2023]