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PD-1 Inhibitor

REGN5678 +/- Cemiplimab for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol (mCRPC cohorts)

(mCRPC cohorts) Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 5 years

Awards & highlights

Study Summary

This trial is testing a new drug, REGN5678, to see if it is safe and effective in treating prostate cancer. The study will also look at how well the drug is tolerated and how it works in the body.

Who is the study for?

This trial is for adults with advanced prostate cancer or renal cell carcinoma that has spread and resisted castration treatment. Participants must have a specific protein on their tumors, have tried certain therapies without success, and cannot have had prior PSMA-targeting therapy or recent biologic treatments. They should not be battling uncontrolled infections like HIV or hepatitis, nor have serious neurological conditions.Check my eligibility

What is being tested?

The study tests REGN5678 alone and combined with Cemiplimab to see how they affect tumor size in patients with metastatic cancers. Part 1 finds safe doses of REGN5678; Part 2 checks the effectiveness at those doses. Sarilumab may also be given to some participants as part of the study.See study design

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, flu-like symptoms such as fever and chills, fatigue, skin reactions, changes in blood pressure or heart rate, liver inflammation which might cause yellowing of skin/eyes (jaundice), immune system overactivity potentially affecting various organs.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has spread, is resistant to hormone therapy, and my PSA is 4 or higher.

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I have prostate cancer and have had at least 2 treatments, including a newer hormone therapy.

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My cancer shows PSMA activity on a PET scan.

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My cancer has worsened after treatment with specific immune therapies and cancer drugs.

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I have metastatic kidney cancer with at least one tumor that can be measured.

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My prostate cancer is confirmed and not purely small cell type.

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My kidney cancer has been confirmed with a lab test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 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 and severity of adverse event of special interests (AESIs)

Incidence and severity of serious adverse events (SAEs)

Incidence and severity of treatment-emergent adverse events (TEAEs)

+4 more

Secondary outcome measures

Concentration of REGN5678 in combination with cemiplimab in serum over time

Concentration of REGN5678 in serum over time

Incidence and severity of AESIs

+9 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

Trial Design

4Treatment groups

Experimental Treatment

Group I: mCRPC - dose expansion cohortExperimental Treatment2 Interventions

Participants will receive the REGN5678 presumptive RP2D(s)

Group II: mCRPC - dose escalation cohortExperimental Treatment2 Interventions

Participants will receive REGN5678 monotherapy for presumptive recommended phase 2 dose(s) (presumptive RP2D) identification Note: Dose escalation on monotherapy lead-in of REGN5678 followed by combination therapy of REGN5678 with full dose cemiplimab is no longer actively enrolling new participants. The prophylactic use of sarilumab is no longer in use.

Group III: ccRCC - dose expansion cohortExperimental Treatment2 Interventions

Participants will receive the REGN5678 presumptive RP2D(s)

Group IV: ccRCC - dose escalation cohortExperimental Treatment2 Interventions

Participants will receive REGN5678 monotherapy for presumptive RP2D identification Note: Dose escalation on monotherapy lead-in of REGN5678 followed by combination therapy of REGN5678 with full dose cemiplimab is no longer actively enrolling new participants. The prophylactic use of sarilumab is no longer in use.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

620 Previous Clinical Trials

380,040 Total Patients Enrolled

Clinical Trials ManagementStudy DirectorRegeneron Pharmaceuticals

4 Previous Clinical Trials

258 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03972657 — Phase 1 & 2

Renal Cell Carcinoma Research Study Groups: ccRCC - dose escalation cohort, ccRCC - dose expansion cohort, mCRPC - dose escalation cohort, mCRPC - dose expansion cohort

Renal Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT03972657 — Phase 1 & 2

Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03972657 — Phase 1 & 2

Frequently Asked Questions

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

How many volunteers have enrolled in this clinical investigation?

"This study is searching for 129 eligible participants and these enrollees can come from multiple locations, such as Yale University School of Medicine in Tampa, Florida or Massachusetts General Hospital in New Haven, Connecticut."

Answered by AI

What other experiments have been conducted utilizing REGN5678?

"REGN5678 first entered the medical landscape in 2010 with City of Hope, and since then 11 trials have been concluded. Currently 56 studies are live across multiple sites; many of these being located in Tampa, Florida."

Answered by AI

What goals is this experiment looking to accomplish?

"Regeneron Pharmaceuticals, the sponsor of this trial, states that its primary outcome measure - taken over a 5 year period - is the incidence and severity of Adverse Event Special Interests (AESIs). Additionally, secondary outcomes such as percentage changes in circulating tumor cell counts and PSA levels will be assessed. These measurements are to take place during both dose escalation and expansion phases."

Answered by AI

Are there multiple instances of this clinical experiment taking place in the US?

"This clinical trial is available at Yale University School of Medicine in Tampa, Massachusetts General Hospital in New Haven, Thomas Jefferson University's Sidney Kimmel Cancer Center and Clinical Research Organization in Boston. Additionally, it can be found at 14 other locations."

Answered by AI

Is the enrollment period for this clinical experiment still ongoing?

"According to the information hosted on clinicaltrials.gov, this trial is actively seeking participants; it was initially posted on August 12th 2019 and most recently modified November 4th 2022."

Answered by AI

To what ailments does REGN5678 commonly provide relief?

"REGN5678 is commonly prescribed to patients with an alk gene mutation, but it can also be a helpful medication for managing advance directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

2019. "A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03972657.

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