This trial is evaluating whether Pembrolizumab/vibostolimab coformuation will improve 3 primary outcomes and 5 secondary outcomes in patients with Hematologic Neoplasms. Measurement will happen over the course of Up to approximately 6 weeks.
This trial requires 180 total participants across 2 different treatment groups
This trial involves 2 different treatments. Pembrolizumab/vibostolimab Coformuation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
The development of novel combinations of targeted agents and immunomodulators are now an area of active research. These new strategies aim at improving efficacy and safety profiles. Pembrolizumab/vibostolimab coformulation has been shown to be safe and effective in patients with previously treated metastatic colorectal cancer and was well tolerated in this unselected population. Clinical studies using this combination are ongoing.
The number of new cases of leukemia, lymphoma, and myeloma annually in the US may be as high as 1,000 per year per 100,000 population. In the US, the incidence of all hematologic neoplasms increased by less than 2% between 1993 and 1999. However, the number of new cases of acute myeloid leukemia per 100,000 population was approximately 10 times higher in the US between 1999 and 2004 than in Europe and Japan.
Pembrolizumab/vibostolimab coformulation has shown promising antitumor activity in both single-agent and combination therapies against advanced hematologic malignancies. Data from a recent study demonstrated the superiority of the dual anti-PD-1 antibody combination therapy over the monotherapeutic regimen of either drug alone.
The risk of developing a hematological malignancy was increased when compared to the general population (OR = 2.3; p < 0.0001), which supports the hypothesis that genetic predisposition plays an important role in the development of hematological tumors.
Hematologic malignancies can have an adverse effect on life expectancy. Some other studies have shown that the overall survival is worse in males than females in both low and high-income groups. In our study, the overall survival was not different between genders, but the recurrence rate was higher in females. Findings from a recent study suggest that there should be a gender difference in management of hematologic malignancies in the future.
Hematological cancers occur most frequently in young adults. Data from a recent study of this study indicate that increasing numbers of children and adolescents are diagnosed with hematological neoplasms each year.
A three-month P+V regimen resulted in an increased risk of serious adverse events compared to placebo, with no difference in OS. No benefit was demonstrated compared to placebo in this retrospective study.
Hematologic neoplasms refer to tumors affecting blood cells including leukemias, lymphomas, myelomas, and monoclonal gammopathies. The most common types of hematologic neoplasms are leukemia (especially acute myeloid leukemia), lymphoma, non-Hodgkin's lymphoma, Hodgkin’s disease, and multiple myeloma. Other hematologic neoplasms include cancers of the bone marrow, blood vessels, gastrointestinal tract, and other organs. There are many different factors involved in the formation of hematological neoplasms including genetic defects, environmental exposures, and infectious agents.
Hematological malignancies often present with nonspecific symptoms such as fatigue, loss of appetite, weight loss, fever, malaise, anemia, and thrombocytopenia. Patients with leukemia or lymphoma usually have a history of recent illness, prolonged fever, and low white blood cell counts (anemia) or high platelet levels (thrombocytopenia). Patients with myeloma typically have bone pain, fever, night sweats, abdominal pain, and decreased appetite. Other signs and symptoms depend on the particular type of neoplasm and include disorders of coagulation, kidney function, liver function, spleen, and peripheral nerves.
In the past 15 years, the incidence of all types of hematological malignancies increased substantially; however, only about one third of these cases were due to common known causes such as tobacco smoking and ionizing radiation exposure. Most of the non-disease related cases occur in older patients and are more likely to be attributable to environmental exposures (e.g., dietary factors, infection, and occupational hazards).
The number of patients treated has increased over the last decade. Patients treated with chemotherapy for leukemias have not shown any survival benefit, while patients treated with multimodality therapy (chemotherapy followed by surgery or radiation therapy) have been able to achieve better survival rates. Patients treated with stem cell transplantation have significantly improved survival.