43 Participants Needed

BXCL701 + Pembrolizumab for Pancreatic Cancer

(EXPEL PANC Trial)

Recruiting at 2 trial locations
NS
PJ
Overseen ByPrincess Jones
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

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

The trial requires a 'washout period' (time without taking certain medications) of at least 2 weeks for prior anti-tumor therapy before starting the study. It's best to discuss your specific medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug combination BXCL701 and Pembrolizumab for pancreatic cancer?

Research shows that combining pembrolizumab with other treatments can help some patients with pancreatic cancer, as seen in a study where a similar drug combination improved disease control and survival in certain patients. This suggests that pembrolizumab might work better when used with other drugs, like BXCL701, for treating pancreatic cancer.12345

Is the combination of BXCL701 and Pembrolizumab safe for humans?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, nausea, and immune-related issues such as thyroid problems and rare cases of type 1 diabetes. While specific safety data for the combination with BXCL701 is not provided, pembrolizumab's safety profile in other conditions suggests it is generally well-tolerated with some risks.16789

What makes the drug combination of BXCL701 and Pembrolizumab unique for pancreatic cancer?

The combination of BXCL701 and Pembrolizumab is unique because it targets multiple pathways in the immune system to enhance the body's ability to fight pancreatic cancer, which is typically resistant to single-agent PD-1 inhibitors like Pembrolizumab alone.12456

What is the purpose of this trial?

This trial is testing a combination of two drugs, BXCL701 and pembrolizumab, in patients with advanced pancreatic cancer. These patients have already tried other treatments without success. The drugs work together to help the immune system better identify and attack cancer cells. Pembrolizumab has shown effectiveness in patients with various cancers, including pancreatic cancer.

Research Team

BW

Benjamin Weinberg, MD

Principal Investigator

Georgetown University

Eligibility Criteria

Adults with metastatic pancreatic ductal adenocarcinoma who've had one prior treatment can join. They must be able to swallow pills, consent to biopsies, and have measurable disease. Women of childbearing age need a negative pregnancy test and agree to contraception. Exclusions include pregnant/breastfeeding women, other recent cancers except certain skin/cervical cancers, uncontrolled medical conditions or heart disease, active infections like HIV/hepatitis, autoimmune diseases needing systemic treatment in the past 2 years (except for some exceptions), and those on steroids/immunosuppressants.

Inclusion Criteria

My pancreatic cancer has spread and is mainly adenocarcinoma.
I can take care of myself and am up and about more than half of my waking hours.
Measurable disease by iRECIST v. 1.1 criteria on baseline imaging
See 13 more

Exclusion Criteria

I haven't had cancer treatment in the last 2 weeks.
Psychiatric illness or social situation that would limit compliance with study requirements
My CNS cancer meets specific eligibility criteria.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BXCL701 and pembrolizumab to determine the 18-week progression-free survival rate

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BXCL701
  • Pembrolizumab
Trial Overview The trial is testing BXCL701 combined with Pembrolizumab in patients who have already undergone one line of therapy for their cancer. It's an open-label study where all participants receive the same treatment without a comparison group. The main goal is to see if this combination helps patients avoid cancer progression for at least 18 weeks.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BXCL701 plus PembrolizumabExperimental Treatment2 Interventions

BXCL701 is already approved in United States for the following indications:

🇺🇸
Approved in United States as BXCL701 for:
  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)
  • Small Cell Neuroendocrine Prostate Cancer (SCNC)
  • Pancreatic Cancer
  • Stage IIb to IV Melanoma
  • Soft Tissue Sarcoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials
355
Recruited
142,000+

BioXcel Therapeutics Inc

Industry Sponsor

Trials
20
Recruited
2,400+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
In a phase IIa study involving 59 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), the CXCR4 antagonist BL-8040 combined with pembrolizumab showed a disease control rate of 34.5% in chemotherapy-resistant patients, with a median overall survival of 3.3 months, and 7.5 months for those receiving it as second-line therapy.
When BL-8040 was combined with pembrolizumab and chemotherapy, the treatment resulted in an objective response rate of 32% and a disease control rate of 77%, indicating that this combination may enhance the effectiveness of chemotherapy in PDAC and should be further investigated in randomized trials.
BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial.Bockorny, B., Semenisty, V., Macarulla, T., et al.[2021]
The BTK inhibitor Tirabrutinib effectively reduces the differentiation of pro-tumorigenic CD1dhiCD5+ regulatory B cells in pancreatic ductal adenocarcinoma, which are known to promote tumor growth.
In mouse models of pancreatic cancer, Tirabrutinib treatment not only decreased the population of these regulatory B cells but also increased the presence of cytotoxic T cells, leading to reduced tumor cell proliferation and growth.
BTK signaling drives CD1dhiCD5+ regulatory B-cell differentiation to promote pancreatic carcinogenesis.Das, S., Bar-Sagi, D.[2020]

References

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial. [2021]
BTK signaling drives CD1dhiCD5+ regulatory B-cell differentiation to promote pancreatic carcinogenesis. [2020]
Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden. [2023]
Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
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