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Checkpoint Inhibitor

Cemiplimab for Cutaneous T-Cell Lymphoma (BIOSELECT Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

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 the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)

Awards & highlights

BIOSELECT Trial Summary

This trial is testing whether the immunotherapy drug cemiplimab can help to treat patients with mycosis fungoides who have failed first line therapy. The primary objective is to see what the response rate is for these patients.

Who is the study for?

Adults with advanced cutaneous T-cell lymphoma (mycosis fungoides) who have not responded to at least one prior therapy can join this trial. They must be able to consent, follow the study plan, and use effective birth control if of childbearing potential. People with certain organ dysfunctions or those taking immunosuppressants cannot participate.Check my eligibility

What is being tested?

The trial is testing cemiplimab's effectiveness in treating mycosis fungoides after other treatments have failed. It aims to see how well patients respond by measuring the reduction in their skin tumors.See study design

What are the potential side effects?

Cemiplimab may cause immune-related side effects such as inflammation in various organs, allergic reactions during infusion into the body, tiredness, stomach issues, changes in blood cells count which could increase infection risk.

BIOSELECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)

This trial's timeline: 3 weeks for screening, Varies for treatment, and the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Response Rate

Secondary outcome measures

Assessment of Progression Free Survival (PFS)

Assessment of Treatment Safety

Duration of Objective Response to Therapy

+4 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Anaemia

20%

Nausea

17%

Fatigue

16%

Vomiting

15%

Decreased appetite

15%

Constipation

11%

Asthenia

11%

Back pain

11%

Pyrexia

11%

Diarrhoea

10%

Arthralgia

Urinary tract infection

Dyspnoea

Abdominal pain

Cough

Oedema peripheral

Hypoalbuminaemia

Headache

Pain in extremity

Rash

Blood creatinine increased

Insomnia

Hypokalaemia

Hypothyroidism

Pruritus

Vaginal haemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pelvic pain

Stomatitis

Neutropenia

Acute kidney injury

Immune-mediated hepatitis

Autoimmune hepatitis

Febrile neutropenia

Pneumonia

Pyelonephritis

Thrombocytopenia

Neutrophil count decreased

Pyelonephritis acute

White blood cell count decreased

Sepsis

Duodenal ulcer

Haematuria

Hydronephrosis

Hyperpyrexia

Kidney infection

Pneumonitis

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Cemiplimab

Investigator Choice (IC) Chemotherapy

BIOSELECT Trial Design

1Treatment groups

Experimental Treatment

Group I: CemiplimabExperimental Treatment1 Intervention

Study treatment includes administration of cemiplimab 350 mg intravenous every 21 days (+/﹣ 3 days)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,196 Total Patients Enrolled

Media Library

Cemiplimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05538988 — Phase 1 & 2

Mycosis Fungoides Research Study Groups: Cemiplimab

Mycosis Fungoides Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05538988 — Phase 1 & 2

Cemiplimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538988 — Phase 1 & 2

Frequently Asked Questions

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

Are there any openings for volunteers in this research project?

"Unfortunately, the information on clinicaltrials.gov reveals that this research endeavour is presently not accepting any more patients. Despite being initially posted in March 1st of 2023 and last updated on September 12th 2022, it does not appear to be enrolling participants anymore; however, 232 other medical studies are actively looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma

2023. "BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538988.

All > Mycosis Fungoides