Q702 + Pembrolizumab for Advanced Solid Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of two treatments: Q702 (an experimental treatment) and pembrolizumab (an immunotherapy drug) for certain advanced cancers, including esophageal, gastric, liver (hepatocellular), and cervical cancers. The goal is to determine the safety and effectiveness of this combination for patients whose cancer has not responded to previous treatments. The trial consists of two parts: one to identify the best dose of Q702 and another to evaluate the combination's effectiveness. Suitable candidates have one of these cancers and have already tried other treatments without success. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering patients a chance to be among the first to benefit from this new approach.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that strongly affect specific liver enzymes (CYP1A2, 2J2, 2C19, 2D6, and 3A4/5) and sensitive medications processed by CYP2C9, 2C19, and 3A4. You must stop these medications for a period of five half-lives (a measure of time it takes for a drug's concentration to reduce by half) before starting the study and throughout the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, researchers found that using Q702 with pembrolizumab is generally safe, as most patients did not experience severe side effects. Reports indicated that patients tolerated the treatment well. Pembrolizumab, one of the drugs in this study, has FDA approval for treating other types of cancer, confirming its safety for those uses. Overall, early research suggests that this combination of treatments is generally safe for patients.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Q702 and pembrolizumab for advanced solid cancers because this duo offers a fresh approach to treatment. Unlike traditional therapies that often focus solely on attacking cancer cells directly, Q702 works by modulating the immune system to enhance its natural ability to fight cancer. When paired with pembrolizumab, an established immunotherapy that blocks a protein called PD-1 to boost immune response, this combination has the potential to improve effectiveness and outcomes for patients. This innovative strategy could lead to more precise and powerful treatment options for those battling advanced cancers.
What evidence suggests that this trial's treatments could be effective for advanced solid cancers?
Research has shown that pembrolizumab effectively treats various solid tumors, such as non-small cell lung cancer and melanoma, by helping patients live longer. It enables the immune system to find and attack cancer cells. In this trial, participants will receive a combination of Q702 and pembrolizumab. Studies have found that Q702 targets certain proteins to boost the immune response and make tumors more responsive to treatments, working well with pembrolizumab. Early data suggests that using Q702 with pembrolizumab is safe and may benefit patients with advanced solid cancers. This combination aims to restore immune function and enhance the effects of immunotherapy.12345
Are You a Good Fit for This Trial?
This trial is for adults with advanced esophageal, gastric/GEJ, hepatocellular, or cervical cancers that worsened after anti-PD1/PD-L1 therapy. Participants must be able to consent, have measurable disease per RECIST v1.1., an ECOG status of 0 or 1, and a life expectancy over 3 months. Pregnant or breastfeeding women and those on certain drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive Q702 in combination with pembrolizumab with a one week on/one week off schedule at selected dose level
Dose Expansion
Participants receive Q702 in combination with a fixed dose of pembrolizumab intravenously once every three weeks at 200 mg
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Q702
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Qurient Co., Ltd.
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
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
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