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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

Must not have

Has known history of, or any evidence of active, non-infectious pneumonitis

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 9 weeks thereafter. after 6 months, every 12 weeks at the physician's discretion, if patient has had cr, pr, or sd > 27 weeks, an average of 4 years.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of or currently have non-infectious lung inflammation.

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I am currently being treated for an infection.

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I have been treated for an autoimmune disease in the last 2 years.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have not received a live vaccine in the last 30 days.

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I am in cohort 10 and have a specific type of tumor.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have an active tuberculosis infection.

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I have active hepatitis B or C.

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I am not currently receiving any cancer treatment like chemotherapy or immunotherapy.

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I have cancer that has spread to my brain or spinal cord.

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 9 weeks thereafter. after 6 months, every 12 weeks at the physician's discretion, if patient has had cr, pr, or sd > 27 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 9 weeks thereafter. after 6 months, every 12 weeks at the physician's discretion, if patient has had cr, pr, or sd > 27 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 9 weeks thereafter. after 6 months, every 12 weeks at the physician's discretion, if patient has had cr, pr, or sd > 27 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-progression Rate (NPR) at 27 Weeks by irRECIST

Secondary study objectives

Clinical Benefit Rate (CBR) Using RECIST v1.1

Evaluation of Tumor Size (Objective Response by irRECIST) to PD-L1 Status (CPS ≥1)

Immune-related Clinical Benefit Rate (CBR) Using irRECIST

+5 more

Other study objectives

Pseudoprogression

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

0 / 16Eligibility criteria met