Pembrolizumab/vibostolimab coformuation for Hematologic Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
Ondokuz Mayıs Universitesi ( Site 0564), Samsun, Turkey
Hematologic Neoplasms+2 More
Pembrolizumab/vibostolimab coformuation - Biological
Eligibility
18+
All Sexes
Eligible conditions
Hematologic Neoplasms

Study Summary

This study is evaluating whether a drug called pembrolizumab can be used to treat blood cancers.

See full description

Eligible Conditions

  • Hematologic Neoplasms
  • Cancer
  • Neoplasms
  • Haematological Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

Week 3
Maximum Concentration (Cmax) of Vibostolimab
Year 2
Lowest Plasma Concentration (Ctrough) of Vibostolimab
Month 24
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of Participants Who Discontinued Study Treatment Due to an AE
Objective Response Rate (ORR)
Month 27
Number of Participants Who Experienced an Adverse Event (AE)
Week 6
Number of Participants with a Dose-Limiting Toxicity (DLT)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Pembrolizumab/vibostolimab coformulation

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.

Pembrolizumab/vibostolimab coformulation
Biological
Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: predose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly predose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks for reporting.

Closest Location

Rutgers Cancer Institute of New Jersey ( Site 0023) - New Brunswick, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hematologic Neoplasms or one of the other 2 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
- Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).
- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.
- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.
Have measurable disease.
Have adequate organ function.
Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the latest developments in pembrolizumab/vibostolimab coformuation for therapeutic use?

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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.

Unverified Answer

How many people get hematologic neoplasms a year in the United States?

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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.

Unverified Answer

What does pembrolizumab/vibostolimab coformuation usually treat?

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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.

Unverified Answer

What are the chances of developing hematologic neoplasms?

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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.

Unverified Answer

How serious can hematologic neoplasms be?

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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.

Unverified Answer

What is the average age someone gets hematologic neoplasms?

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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.

Unverified Answer

Has pembrolizumab/vibostolimab coformuation proven to be more effective than a placebo?

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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.

Unverified Answer

What is hematologic neoplasms?

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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.

Unverified Answer

What are the signs of hematologic neoplasms?

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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.

Unverified Answer

What is the primary cause of hematologic neoplasms?

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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).

Unverified Answer

What are common treatments for hematologic neoplasms?

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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.

Unverified Answer
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