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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

Estudo de pembrolizumabe com terapia de quimiorradioterapia concomitante seguida de pembrolizumabe com ou sem olaparibe em câncer de pulmão de não pequenas células em estágio 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

Estudo de pembrolizumabe administrado com ipilimumabe ou placebo em participantes com câncer de pulmão de não pequenas células metastático não 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

Estudo de quimiorradioterapia com ou sem pembrolizumabe para o tratamento de câncer cervical localmente avançado

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

Estudo de lenvatinibe em combinação com pembrolizumabe versus padrão de tratamento em participantes com câncer colorretal metastático

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

Estudo de primeira linha sobre carcinoma esofágico com quimioterapia vs. quimioterapia mais pembrolizumabe

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

Estudo de pembrolizumabe mais quimioterapia versus placebo mais quimioterapia para câncer de mama metastático ou inoperável HR+/HER2- localmente recidivante

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,

Estudo de olaparibe mais pembrolizumabe versus quimioterapia mais pembrolizumabe após indução com quimioterapia de primeira linha mais pembrolizumabe em câncer de mama triplo 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

Estudo de pembrolizumabe ou placebo com quimiorradioterapia em participantes com carcinoma de células escamosas de cabeça e pescoço localmente avançado

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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