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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR PEMBROLIZUMAB


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Biosimilar Clinical Trials for pembrolizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT03988036 ↗ A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) Recruiting Amgen Phase 2 2020-08-18 Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.
NCT03988036 ↗ A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) Recruiting Merck Sharp & Dohme Corp. Phase 2 2020-08-18 Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.
NCT03988036 ↗ A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) Recruiting NanoString Technologies, Inc. Phase 2 2020-08-18 Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.
NCT03988036 ↗ A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) Recruiting West German Study Group Phase 2 2020-08-18 Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for pembrolizumab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01042379 ↗ I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer Recruiting QuantumLeap Healthcare Collaborative Phase 2 2010-03-01 The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
NCT01174121 ↗ Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer Suspended National Cancer Institute (NCI) Phase 2 2010-08-26 Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see if this treatment is safe. Eligibility: - Adults age 18-70 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
NCT01295827 ↗ Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001) Active, not recruiting Merck Sharp & Dohme Corp. Phase 1 2011-03-01 This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and compare every 2 week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and high doses of study drug identified in Parts A and B in participants with advanced or metastatic MEL. Part E (closed with Amendment 7) will explore low, medium, and high doses of study drug in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC. Part F will explore low and high doses of study drug in treatment-naive and previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene expression. In Parts D and F and some of Part B participants will be randomized to one dose level. The primary hypotheses are the following: that pembrolizumab has acceptable safety and tolerability; and that pembrolizumab shows a clinically meaningful response rate (RR) or disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not), and a clinically meaningful RR in participants with NSCLC, especially a clinically meaningful RR in those participants with either cancer, whose tumors express PD-L1.
NCT01469455 ↗ DNA Repair Inhibitor & Irradiation on Melanoma Completed DNA Therapeutics Phase 1 2011-10-01 Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation. DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design. The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for pembrolizumab

Condition Name

Condition Name for pembrolizumab
Intervention Trials
Melanoma 110
Non-small Cell Lung Cancer 101
Breast Cancer 75
Head and Neck Squamous Cell Carcinoma 66
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Condition MeSH

Condition MeSH for pembrolizumab
Intervention Trials
Carcinoma 396
Carcinoma, Non-Small-Cell Lung 297
Lung Neoplasms 262
Melanoma 190
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Clinical Trial Locations for pembrolizumab

Trials by Country

Trials by Country for pembrolizumab
Location Trials
China 710
Japan 655
France 649
United States 6,083
Spain 516
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Trials by US State

Trials by US State for pembrolizumab
Location Trials
California 411
Texas 384
New York 346
Pennsylvania 278
Florida 258
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Clinical Trial Progress for pembrolizumab

Clinical Trial Phase

Clinical Trial Phase for pembrolizumab
Clinical Trial Phase Trials
Phase 4 6
Phase 3 179
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for pembrolizumab
Clinical Trial Phase Trials
Recruiting 804
Not yet recruiting 423
Active, not recruiting 310
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Clinical Trial Sponsors for pembrolizumab

Sponsor Name

Sponsor Name for pembrolizumab
Sponsor Trials
Merck Sharp & Dohme Corp. 711
National Cancer Institute (NCI) 179
Merck Sharp & Dohme LLC 89
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Sponsor Type

Sponsor Type for pembrolizumab
Sponsor Trials
Industry 1713
Other 1625
NIH 185
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Pembrolizumab: Clinical Trials, Market Analysis, and Projections

Introduction to Pembrolizumab

Pembrolizumab, marketed under the brand name Keytruda, is a monoclonal antibody that targets the PD-1 receptor, playing a crucial role in cancer immunotherapy. It has revolutionized the treatment of various types of cancer, including non-small cell lung cancer (NSCLC), head and neck cancer, and others.

Ongoing Clinical Trials

Combination Therapy in NSCLC

One significant clinical trial involves the combination of pembrolizumab with bemcentinib, pemetrexed, and carboplatin in adult participants with untreated non-squamous NSCLC. This Phase 1/Phase 2 study aims to determine the safety, tolerability, and preliminary anti-tumor activity of this combination. The trial focuses on participants with locally advanced or metastatic NSCLC, including those with STK11 mutations and no actionable mutations[1].

Subcutaneous Pembrolizumab in NSCLC

Another notable trial is the MK-3475A-D77 study, which compares the pharmacokinetics and efficacy of subcutaneous pembrolizumab plus chemotherapy to intravenous pembrolizumab plus chemotherapy in patients with NSCLC. The results have shown noninferiority in pharmacokinetic parameters and consistent efficacy and safety profiles, suggesting potential benefits in patient experience and access to treatment[3].

Adjuvant Therapy in Squamous Cell Carcinoma

A randomized, double-blind study is comparing pembrolizumab with placebo as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) who have undergone surgery and radiotherapy. The primary goal is to assess whether pembrolizumab can increase recurrence-free survival (RFS) compared to placebo[4].

Market Analysis

Current Market Trends

The pembrolizumab market has seen significant growth since its introduction. In China, for example, the sales revenue of pembrolizumab increased substantially from 2018 to 2020, with a Compound Annual Growth Rate (CAGR) of 284.67%. This growth is attributed to the drug's effectiveness and the expansion of approved indications[2].

Market Drivers

Several factors are driving the growth of the pembrolizumab market:

  • Increased Prevalence of Cancer: The global rise in cancer cases is a major driver, as pembrolizumab is used to treat a wide range of cancers, including lung, head and neck, and stomach cancers[5].
  • Technological Advancements: Continuous R&D in cancer immunotherapy and the specificity and effectiveness of pembrolizumab contribute to market growth[5].
  • Healthcare Expenditure and Insurance: Rising healthcare expenditure and increased healthcare insurance coverage are expected to fuel market growth through 2030[5].

Market Challenges

Despite the positive trends, there are challenges to consider:

  • Side Effects: Pembrolizumab can cause side effects such as musculoskeletal pain, fever, cough, and difficulty breathing, which may hamper market growth[5].
  • Competition: The approval of other PD-1 drugs, such as those from Junshi Biosciences, may lead to increased competition and potentially lower prices in certain markets[2].

Market Projections

The pembrolizumab market is expected to continue expanding through 2030. The market size is projected to grow due to the increasing adoption of pembrolizumab for various cancer treatments and the rising geriatric population. Technological advancements and the specificity of cancer immunotherapy will also contribute to this growth[5].

Regional Market Insights

China Market

In China, pembrolizumab has seen rapid growth since its market entry. Despite the potential for price reductions due to increased competition, the market is expected to expand driven by the drug's effectiveness and unsaturated demand[2].

Expert Insights

"Pembrolizumab has helped transform the way we treat some of the deadliest forms of cancer, yet we continue to pursue additional innovations that may benefit patients," said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. This sentiment reflects the ongoing efforts to improve and expand the use of pembrolizumab[3].

Key Takeaways

  • Clinical Trials: Ongoing trials are exploring the safety, tolerability, and efficacy of pembrolizumab in combination with other therapies and in different formulations.
  • Market Growth: The pembrolizumab market is driven by increasing cancer prevalence, technological advancements, and rising healthcare expenditure.
  • Challenges: Side effects and competition from other PD-1 drugs are potential challenges.
  • Projections: The market is expected to continue growing through 2030 due to its effectiveness and expanding indications.

FAQs

What is the primary purpose of the clinical trial combining pembrolizumab with bemcentinib, pemetrexed, and carboplatin?

The primary purpose is to determine the safety, tolerability, and preliminary anti-tumor activity of this combination in adult participants with untreated non-squamous NSCLC[1].

How does the subcutaneous formulation of pembrolizumab compare to the intravenous formulation?

The subcutaneous formulation has demonstrated noninferiority in pharmacokinetic parameters and consistent efficacy and safety profiles compared to the intravenous formulation, potentially improving patient experience and access to treatment[3].

What are the main drivers of the pembrolizumab market growth?

The main drivers include the increasing prevalence of cancer, technological advancements in cancer immunotherapy, and rising healthcare expenditure and insurance coverage[5].

What are some potential challenges facing the pembrolizumab market?

Potential challenges include side effects associated with pembrolizumab and increased competition from other PD-1 drugs[2][5].

What are the projections for the pembrolizumab market through 2030?

The market is expected to continue growing due to the drug's effectiveness, expanding indications, and rising healthcare expenditure and insurance coverage[5].

Sources

  1. Mount Sinai: A Study to Investigate the Safety, Tolerability, and Preliminary Anti-tumor Activity of Bemcentinib in Combination With Pembrolizumab Plus Pemetrexed and Carboplatin in Adult Participants With Untreated Non-squamous Non-small Cell Lung Cancer.
  2. Research and Markets: Investigation Report on China's Pembrolizumab Market, 2021-2025.
  3. Onclive: Subcutaneous Pembrolizumab Plus Chemo Meets Pharmacokinetic End Points in NSCLC.
  4. UCSD Clinical Trials: Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiotherapy in Participants With High-Risk Locally Advanced Cutaneous Squamous Cell Carcinoma.
  5. Allied Market Research: Pembrolizumab Market Size and Industry Growth By 2030.

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