36 Participants Needed

Paclitaxel + Pembrolizumab + Olaparib for Gastric Cancer

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Overseen ByColleen Apostol, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs like moderate or strong CYP3A inhibitors. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination of Paclitaxel, Pembrolizumab, and Olaparib for gastric cancer?

Research shows that combining Olaparib with Paclitaxel improved survival in patients with advanced gastric cancer, especially those with low ATM protein levels. Additionally, Pembrolizumab has been studied as a treatment for advanced gastric cancer, showing potential benefits in certain patients.12345

Is the combination of Paclitaxel, Pembrolizumab, and Olaparib safe for humans?

Studies have shown that Olaparib combined with Paclitaxel has been tested for safety in patients with advanced gastric cancer and other solid tumors, indicating it is generally safe for human use. However, specific safety data for the combination with Pembrolizumab is not detailed in the available research.34678

How is the drug combination of Paclitaxel, Pembrolizumab, and Olaparib unique for treating gastric cancer?

This drug combination is unique because it combines a chemotherapy drug (Paclitaxel), an immunotherapy drug (Pembrolizumab), and a targeted therapy drug (Olaparib) to potentially improve outcomes in gastric cancer, especially in patients with specific genetic markers like low ATM protein levels. This approach aims to enhance the effectiveness of treatment by attacking the cancer in multiple ways.345910

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).

Research Team

KB

Katherine Bever, MD

Principal Investigator

Johns Hopkins Medical Institution

Eligibility Criteria

Adults over 18 with advanced gastric or gastroesophageal cancer, who have failed one prior therapy and have a measurable lesion. They must be in good physical condition (ECOG 0-1), not pregnant, willing to use birth control, and able to consent. Excluded are those with brain metastases, certain allergies, recent other treatments or vaccines, active infections like HIV/hepatitis B/C, severe illnesses or conditions that could affect study participation.

Inclusion Criteria

I agree to undergo a biopsy.
I am fully active or restricted in physically strenuous activity but can do light work.
My cancer is in an advanced stage in my stomach or where my esophagus meets my stomach.
See 16 more

Exclusion Criteria

Allergy to dexamethasone, diphenhydramine and famotidine
I have cancer spread to my brain or spinal cord and need treatment.
I am not pregnant or breastfeeding.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Paclitaxel, Olaparib, and Pembrolizumab

Until treatment discontinuation or end of study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

  • Olaparib
  • Paclitaxel
  • Pembrolizumab
Trial Overview The trial is testing the combination of Paclitaxel (a chemotherapy drug), Olaparib (a PARP inhibitor) and Pembrolizumab (an immunotherapy drug) in patients who've had previous treatment for advanced Gastric Cancer. The goal is to assess safety and how well this combo works against the cancer.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort 1 - Measurable DiseaseExperimental Treatment3 Interventions
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Group II: Arm 2: Cohort 2-Unmeasurable DiseaseExperimental Treatment3 Interventions
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Lynparza for:
  • Breast cancer
  • Ovarian cancer
  • Fallopian tube cancer
  • Peritoneal cancer
  • Pancreatic cancer
  • Prostate cancer
  • Endometrial cancer
🇺🇸
Approved in United States as Lynparza for:
  • Ovarian, fallopian tube, and primary peritoneal cancer
  • Breast cancer
  • Prostate cancer
  • Pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

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

Niraparib has been approved by the FDA for patients with complete or partial response to first-line platinum-based chemotherapy, regardless of their BRCAm or HRD status, expanding treatment options for more patients.
Olaparib, in combination with bevacizumab, has also received FDA approval for patients with epithelial ovarian cancer, indicating that PARP inhibitors are now beneficial not only for BRCAm and HRD-deficient patients but also for those with HRD-proficient tumors.
PARP inhibitors in the treatment of ovarian cancer: a review.Washington, CR., Moore, KN.[2023]
In a study of 120 ovarian cancer patients, the combination of olaparib with paclitaxel and carboplatin significantly improved the objective remission rate and disease control rate compared to the standard treatment with paclitaxel and carboplatin alone.
The addition of olaparib also resulted in lower levels of tumor markers and a reduced rate of tumor metastasis after one year, all without increasing the incidence of adverse effects.
Olaparib and paclitaxel in combination with carboplatin in treatment of ovarian cancer: influence on disease control.Zhang, H., Zhang, Y.[2022]
The phase 3 GOLD study involving 525 patients with advanced gastric cancer found that the combination of olaparib and paclitaxel did not significantly improve overall survival compared to placebo plus paclitaxel, with median survival times of 8.8 months versus 6.9 months, respectively.
Safety analysis revealed that the most common severe adverse events were neutropenia and leucopenia, with similar rates in both treatment groups, indicating that while olaparib was not effective in improving survival, it had a manageable safety profile when combined with chemotherapy.
Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial.Bang, YJ., Xu, RH., Chin, K., et al.[2022]

References

PARP inhibitors in the treatment of ovarian cancer: a review. [2023]
Olaparib and paclitaxel in combination with carboplatin in treatment of ovarian cancer: influence on disease control. [2022]
Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. [2022]
Randomized, Double-Blind Phase II Trial With Prospective Classification by ATM Protein Level to Evaluate the Efficacy and Tolerability of Olaparib Plus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer. [2022]
Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients. [2022]
Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study). [2021]
Pharmacokinetics and safety of olaparib tablets as monotherapy and in combination with paclitaxel: results of a Phase I study in Chinese patients with advanced solid tumours. [2020]
New Adjuvant Treatment for High-Risk Early Breast Cancer. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. [2022]
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