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Tyrosine Kinase Inhibitor

PT2385 for Kidney Cancer

Phase 1

Waitlist Available

Research Sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility Criteria Checklist

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

Must have

Has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen

Received no more than three prior systemic treatment regimens in the advanced or metastatic setting

Must not have

Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression

Has an active infection requiring systemic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

Summary

This trial is testing a new drug, MK-3795, for patients with advanced kidney cancer. The goal is to find the maximum tolerated dose (MTD) of the drug for future trials.

Who is the study for?

This trial is for adults over 18 with advanced clear cell renal cell carcinoma who've had at least one prior treatment but no more than three, including a specific type of drug targeting blood vessel growth. They must expect to live at least 3 months, be able to take pills, and use approved birth control if necessary. Exclusions include recent major surgery, other clinical trials participation, untreated brain metastases, uncontrolled hypertension, certain heart conditions within the past 6 months.

What is being tested?

The study tests different doses of MK-3795 alone and in combination with Nivolumab or Cabozantinib to find the highest dose patients can tolerate without severe side effects (MTD) and recommend for future studies (RP2D). It's divided into three parts: testing MK-3795 alone; then with Nivolumab; and finally with Cabozantinib.

What are the potential side effects?

Possible side effects may include typical reactions from cancer treatments such as fatigue, nausea, liver function changes. Since it involves immune therapy drugs like Nivolumab and targeted therapies like Cabozantinib there could also be risks of immune-related inflammation or high blood pressure.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has spread and worsened despite treatment.

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I've had 3 or fewer treatments for my advanced cancer.

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I have had 1 or 2 treatments targeting blood vessel growth in my cancer.

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I have been treated with a medication targeting blood vessel growth in cancer.

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I can take pills by mouth.

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I am 18 years old or older.

Exclusion Criteria

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

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I have untreated brain metastasis or a history of leptomeningeal disease or spinal cord compression.

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I am currently being treated for an infection.

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I have not had major surgery in the last 4 weeks.

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I am HIV positive.

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My blood pressure is high and not well-managed.

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I have a history of congenital long QT syndrome.

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I have previously undergone immunotherapy.

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I am taking or will need to take warfarin for blood thinning.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Accumulation Ratio (RAC)

Antitumor Activity

Apparent Clearance (CL/F) of Study Treatment

+22 more

Side effects data

From 2023 Phase 2 trial • 4 Patients • NCT03108066

100%

Nausea

75%

Dry eye

75%

Aphasia

75%

Fatigue

50%

Anxiety

50%

Insomnia

50%

Hyperglycaemia

50%

Bradycardia

50%

Vision blurred

50%

Arthralgia

50%

Neck pain

50%

Pain in extremity

50%

Headache

25%

Oropharyngeal pain

25%

COVID-19

25%

Anaemia

25%

Diarrhoea

25%

Hypotension

25%

Hypophosphataemia

25%

Gastrooesophageal reflux disease

25%

Back pain

25%

Macule

25%

Herpes zoster cutaneous disseminated

25%

Weight decreased

25%

Urinary retention

25%

Hypercalcaemia

25%

Photopsia

25%

Retinal haemorrhage

25%

Oedema peripheral

25%

Upper respiratory tract infection

25%

Muscle spasms

25%

Irritability

25%

Dyspnoea

25%

Pruritus

25%

Rash maculo-papular

25%

Oral pain

25%

Dry mouth

25%

Cognitive disorder

25%

Dysgeusia

25%

Vitreous floaters

25%

Abdominal pain upper

25%

Constipation

25%

Bronchitis

25%

Mammogram abnormal

25%

Hypercholesterolaemia

25%

Hypertriglyceridaemia

25%

Myalgia

25%

Disturbance in attention

25%

Dizziness

25%

Dysaesthesia

25%

Neuralgia

25%

Post herpetic neuralgia

25%

Tremor

25%

Depression

25%

Proteinuria

25%

Sinus pain

100%

80%

60%

40%

20%

Study treatment Arm

MK-3795

Awards & Highlights

No Placebo-Only Group

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3: MK-3795 + CabozantinibExperimental Treatment2 Interventions

Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 in combination with cabozantinib 20mg up to 60mg orally QD for up to approximately 1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.

Group II: Part 2: MK-3795 + Nivolumab + BelzutifanExperimental Treatment3 Interventions

Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 orally in combination with nivolumab 240mg by IV infusion over \~60 minutes every 2 weeks for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. As per Amendment 09 (29 March 2024), participants will not receive MK-3795. Participants receive nivolumab 240mg by IV infusion over \~60 minutes every 2 weeks in combination with belzutifan 120 mg once daily (QD) for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. If participants experience an adverse event, then nivolumab will be discontinued and participants will continue to receive belzutifan 120 mg QD alone for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.

Group III: Part 1: MK-3795Experimental Treatment1 Intervention

Participants with advanced ccRCC receive MK-3795 at an initial dose level of 100mg orally, twice daily (BID) up to approximately 3 weeks. Dose levels will be escalated to identify the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for MK-3795. Each escalated dose will be continued for up to approximately 3 weeks before escalating a dose again until a dose limiting toxicity (DLT) is experienced. Thereafter, participants receive RP2D dose of MK-3795 for up to 2 cycles (each cycle length = 28 days) for up to approximately 1 year. Participants may continue to receive MK-3795 beyond 1 year at the discretion of the Sponsor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

PT-2385

Not yet FDA approved

Cabozantinib

FDA approved

0 / 14Eligibility criteria met