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Monoclonal Antibodies

Pembrolizumab for Advanced Cancers

Phase 2

Waitlist Available

Led By Aung Naing

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Have one of the specified advanced (unresectable and/or metastatic) solid tumor indications that has progressed following standard therapies, where standard therapies are available

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial looks at how well pembrolizumab works on patients with rare tumors that can't be removed or have spread. Monoclonal antibodies, like pembrolizumab, may block certain proteins to help control tumor growth.

Who is the study for?

This trial is for patients with rare, inoperable or metastatic tumors who've had previous treatments fail within 6 months. They must have measurable disease, be willing to use birth control and provide tissue samples. Excluded are those with active hepatitis B/C, CNS metastases (for certain cohorts), other cancer treatments ongoing, immunodeficiency issues, known pneumonitis or TB history.Check my eligibility

What is being tested?

The study tests pembrolizumab's effectiveness on various advanced solid tumors that can't be surgically removed or have spread. Pembrolizumab is a monoclonal antibody designed to block proteins on white blood cells to potentially boost the immune system against tumor growth.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation of organs like lungs (pneumonitis) or intestines (colitis), liver problems (hepatitis), hormone gland issues (thyroid, adrenal glands), skin reactions, infusion-related reactions and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My advanced cancer has worsened after standard treatments.

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My scans show no brain metastases.

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I have a tumor that can be safely biopsied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Non-progression rate defined as the proportion of subjects in the analysis population who have no progression of disease

Secondary outcome measures

Blood pressure

Clinical benefit (CR, PR, or stable disease [SD] >= 4 months)

Duration of response defined as time from first response to disease progression in subjects who achieve SD >= 4 months or better by RECIST 1.1 or irRECIST

+12 more

Other outcome measures

Pseudoprogression

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or toxicity. Patients with clinical response or disease stabilization may continue treatment for up to an additional 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,624 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,996 Total Patients Enrolled

Aung NaingPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

549 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02721732 — Phase 2

Vascular Tumor Research Study Groups: Treatment (pembrolizumab)

Vascular Tumor Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02721732 — Phase 2

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02721732 — Phase 2

Frequently Asked Questions

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

What reports have been documented concerning the application of Pembrolizumab?

"Currently, there are 961 trials in progress for Pembrolizumab with 122 of those being Phase 3. The majority of sites administering this medication can be found in Houston, TX but numerous other locations have clinical studies underway as well. Altogether these institutes account for 35731 active research centers."

Answered by AI

Is recruitment still ongoing for this research project?

"This clinical trial is currently not accepting any new participants. Initially posted on August 15th 2016, the study was last updated April 20th 2022. Alternately, 5117 trials are recruiting patients with carcinoma and 961 studies are looking for volunteers to take part in pembrolizumab tests."

Answered by AI

How many participants has this clinical trial enrolled?

"This trial has come to a conclusion and is no longer recruiting participants. It was first posted on August 15th 2016, with the latest edit taking place on April 20th 2022. Those searching for other clinical trials may find success in looking at 5117 studies enrolling patients with carcinoma or small cell cancer, plus 961 studies involving Pembrolizumab treatments which are actively seeking new test subjects."

Answered by AI

What pathologies can Pembrolizumab ameliorate?

"Pembrolizumab is a cancer treatment that can be used to address malignancies as well as unresectable melanoma, microsatellite instability high states, and post-chemotherapy disease progression."

Answered by AI

What safety protocols are in place for the administration of Pembrolizumab?

"In light of the Phase 2 clinical trial, which has not yet yielded any efficacy data but some safety information, we have given Pembrolizumab a score of 2."

Answered by AI

What primary goals has this trial set out to accomplish?

"This clinical trial will track the occurrence of adverse events over 27 weeks as its primary outcome measure. Additionally, laboratory safety assessments such as blood and urine samples to ensure normal ranges, Clinical benefit (CR, PR, or stable disease [SD] >= 4 months) monitored via RECIST 1.1 or irRECIST protocols; and overall survival summarised using Kaplan-Meier methodology with 25th/50th/75th percentiles & associated 2-sided 95% confidence intervals along with censored observations percentages are also tracked for evaluation purposes."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Efficacy of Pembrolizumab in Patients with Pituitary Carcinoma: Report of Four Cases from a Phase II Study

Majd, Nazanin, Steven G Waguespack, Filip Janku, Siqing Fu, Marta Penas-Prado, Mingxuan Xu, Anas Alshawa, et al.. 2020. “Efficacy of Pembrolizumab in Patients with Pituitary Carcinoma: Report of Four Cases from a Phase II Study”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-001532.

Gynecologic OncologyJournal

Phase II Study of Pembrolizumab Efficacy and Safety in Women with Recurrent Small Cell Neuroendocrine Carcinoma of the Lower Genital Tract

Frumovitz, Michael, Shannon N. Westin, Gloria Salvo, Abdulrazzak Zarifa, Mingxuan Xu, Timothy A. Yap, Ahnert J. Rodon, et al.. 2020. “Phase II Study of Pembrolizumab Efficacy and Safety in Women with Recurrent Small Cell Neuroendocrine Carcinoma of the Lower Genital Tract”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2020.05.682.

Journal for ImmunoTherapy of CancerJournal

Phase 2 Study of Pembrolizumab in Patients with Advanced Rare Cancers

Naing, Aung, Funda Meric-Bernstam, Bettzy Stephen, Daniel D Karp, Joud Hajjar, Jordi Rodon Ahnert, Sarina A Piha-Paul, et al.. 2020. “Phase 2 Study of Pembrolizumab in Patients with Advanced Rare Cancers”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2019-000347.

Investigational New DrugsJournal