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Study Keyword: Programmed Cell Death Receptor Ligand 1

This is a safety, efficacy, and pharmacokinetics (PK) study of vibostolimab (MK-7684) as monotherapy and in combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in adults with metastatic solid tumors for which there is no available therapy that is expected to convey clinical benefit. Part A of this study is a dose escalation and confirmation phase to estimate the recommended Phase 2 dose (RPTD) for vibostolimab monotherapy or in combination with pembrolizumab, pemetrexed, and carboplatin. Part A will also evaluate the anti-tumor activity of vibostolimab in combination with pembrolizumab plus pemetrexed and carboplatin in participants with non-small cell lung cancer (NSCLC) and vibostolimab (at two dose levels) in combination with pembrolizumab in Japanese participants with gastric cancer. Part B will evaluate the anti-tumor activity of vibostolimab at the RPTD when used as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors in a non-randomized study design. Part B will also evaluate 2 doses of vibostolimab in combination with pembrolizumab in participants with programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized study design. Part B is expanded with Amendment 11 to include an additional arm that will compare the safety and PK of a fixed dose of pembrolizumab/vibostolimab coformulation (MK-7684A) to vibostolimab in combination with pembrolizumab administered as separate intravenous infusions. Part A is expanded with Amendment 12 to include an additional arm that will compare the safety and PK of vibostolimab plus pembrolizumab plus the investigator’s choice of platinum agent (carboplatin or cisplatin), and etoposide. Part B is expanded with Amendment 12 to include evaluation of efficacy of vibostolimab plus pembrolizumab plus the investigator’s choice of platinum agent (carboplatin or cisplatin), and etoposide and efficacy of pembrolizumab/vibostolimab coformulation in participants from mainland China. The primary hypotheses are that vibostolimab administered as monotherapy or in combination with pembrolizumab is safe and tolerable when administered at the RPTD and that pembrolizumab/vibostolimab coformulation is safe and tolerable when administered as a fixed dose.

Study Keyword: Programmed Cell Death Receptor Ligand 1

Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

March 10, 2022

By Tyler Kalist

This is a safety, efficacy, and pharmacokinetics (PK) study of vibostolimab (MK-7684) as monotherapy and in combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in adults with metastatic solid

Estudio de pembrolizumab con quimiorradioterapia concomitante seguido de pembrolizumab con o sin olaparib en el cáncer de pulmón de células no pequeñas en estadio III

March 7, 2022

By clique_admin

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with

Estudio de pembrolizumab administrado con ipilimumab o placebo en participantes con cáncer de pulmón de células no pequeñas metastásico no tratado

March 7, 2022

By Support_Clique

The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer

Estudio de quimiorradioterapia con o sin pembrolizumab para el tratamiento del cáncer de cuello uterino localmente avanzado

March 7, 2022

By Tyler Kalist

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The

Estudio de lenvatinib en combinación con pembrolizumab frente al estándar de atención en participantes con cáncer colorrectal metastásico

March 7, 2022

By Tyler Kalist

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare

Estudio de carcinoma esofágico de primera línea con quimioterapia frente a quimioterapia más pembrolizumab

March 7, 2022

By Tyler Kalist

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin

Estudio de pembrolizumab más quimioterapia frente a placebo más quimioterapia para cáncer de mama inoperable o metastásico localmente recurrente HR+/HER2-

March 7, 2022

By Tyler Kalist

The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive,

Estudio de olaparib más pembrolizumab frente a quimioterapia más pembrolizumab después de la inducción con quimioterapia de primera línea más pembrolizumab en el cáncer de mama triple negativo

March 7, 2022

By Tyler Kalist

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast

Estudio de pembrolizumab o placebo con quimiorradiación en participantes con carcinoma de células escamosas localmente avanzado de cabeza y cuello

March 7, 2022

By clique_admin

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally

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