What the trial was testing
The trial enrolled 170 patients with pancreatic cancer. The study was sponsored by Changhai Hospital and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Patients lived a median of nearly 25 months with the combination treatment, compared to about 22 months with chemotherapy.
The Lancet. Oncology · 2021 · NCT02704156
These findings — that patients lived longer with the immunotherapy combination than with standard chemotherapy — were published in the The Lancet. Oncology and represent the headline result of the study.
Researchers tracked outcomes across 170 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with pancreatic cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial testing study and the combination is not yet FDA-approved for recurrent pancreatic cancer. Pembrolizumab is FDA-approved for some cancers but not specifically this use. If your pancreatic cancer has returned after surgery, talk to your doctor about clinical trials testing immunotherapy combinations or other approved treatment options.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open pancreatic cancer trials
DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 With mFOLFIRINOX in PAncreatic Cancer
The goal of this clinical trial is to estimate the antitumor response of mFOLFIRINOX + Dostarlimab + oral HD vitamin D3 in patients with non-pretreated histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas. The patients must have an Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 or 1 and adequate organ functions. The main objective of the study will be assessed by estimating Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease. The Secondary objectives are : * To assess the safety and tolerability of mFOLFIRINOX + Dostarlimab + HD Vitamin D according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by evaluating the Median Progression Free Survival (mPFS) in months, the Median Overall Survival (mOS) in months, the Median Duration of Response (mDOR) in months and Clinical benefit rate according to RECIST 1.1 (CBR) * To further evaluate the antitumor efficacy of mFOLFIRINOX + Dostarlimab + oral HD Vitamin D by evaluating the type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings There are also exploratory objectives to better understand the pancreatic adenocarcinoma. Participants will be cared for in the digestive oncology department. A selection review will be carried out to check compliance with the study eligibility criteria. Patients included in the study will be treated with 4 cycles of induction therapy. Each cycle lasts 6weeks and includes chemotherapy such as mFolfirinox D1,D15 and D29, combined with dostarlimab 500 mg every 3 weeks and daily oral vitamin D3. At the end of the induction treatment period, maintenance treatment will be instituted with LV5FU chemotherapy combined with dostarlimab 1000 mg every 6 weeks and daily oral vitamine D3. Treatment will be maintained until progression or unacceptable toxicity. Throughout this period, patients will be monitored for their safety. Imaging examinations will also be carried out to monitor the progression of tumour disease.
A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors
The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors. For this, the researchers will study and analyze: * the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose. * the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses. * the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses. Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse. The study participants will take part in one of the eight distinct groups or "intervention cohorts" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase. Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems. Participants will visit the study site: * at least twice before the treatment starts * multiple times when they start taking the treatment * once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram * check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan * take tumor samples The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.