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PI3K Inhibitor

MK-3475 for Peripheral T-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Henry Fung, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new combination therapy for patients with relapsed or refractory NKTCL, who have received at least one prior systemic therapy. The primary endpoint for this trial is progression-free survival.

Eligible Conditions
  • Peripheral T-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine Overall Response Rate by 4 Cycles of Combination of Pembrolizumab and Copanlisib
Progression Free Survival
Recommended Phase II Dose of the Combination of Pembrolizumab and Copanlisib
Secondary outcome measures
Expression of PD-1, PD-L1 and Tumor Infiltrating Lymphocytes (TIL) in Pre-treatment Tumor Specimens
Maximum Tolerated Dose of Pembrolizumab and Copanlisib
Overall Survival
Other outcome measures
PD-1 Expression and Leukocyte Activation Markers on Circulating Lymphocytes Pre-treatment

Side effects data

From 2020 Phase 2 trial • 65 Patients • NCT02085070
83%
Fatigue
62%
Cough
50%
Constipation
50%
Dyspnea
43%
Back pain
40%
Anorexia
36%
Headache
33%
Diarrhea
31%
Pain in extremity
29%
Nausea
24%
Rash maculo-papular
24%
Dizziness
24%
Edema limbs
21%
Anxiety
17%
Insomnia
17%
Hypertension
14%
Abdominal pain
14%
Thromboembolic event
14%
Hypothyroidism
12%
Non-cardiac chest pain
12%
Pruritus
12%
Allergic rhinitis
10%
Vomiting
10%
Pain
10%
Muscle weakness lower limb
10%
Floaters
7%
Gastroesophageal reflux disease
7%
Dyspepsia
7%
Aspartate aminotransferase increased
7%
Fever
7%
Arthralgia
7%
Neck pain
7%
Chest wall pain
7%
Depression
7%
Creatinine increased
7%
Bone pain
7%
Seizure
7%
Alanine aminotransferase increased
5%
Cognitive disturbance
5%
Pneumonitis
5%
Nasal congestion
2%
Chills
2%
Adrenal Insufficienvy
2%
Acute Kidney Injury
2%
Hypokalemia
2%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-small Cell Lung Cancer Patients
Melanoma Patients

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles
Group II: CombinationActive Control2 Interventions
MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-3475
2014
Completed Phase 2
~1290

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,492 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,987 Total Patients Enrolled
Henry Fung, MDPrincipal InvestigatorFox Chase Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
2016. "Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02535247.
~2 spots leftby Apr 2025
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