PruritusPhase 1NCT06931119
Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus in Solid Cancer Patients
A Phase 1 study testing EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd. in people with Pruritus, run by Rabin Medical Center.
Trial summary
Pruritus, commonly known as itching, is an unpleasant sensation that triggers the urge to scratch, which may provide temporary relief. Pruritus can be intermittent or persistent, localized or widespread, and may be associated with medication use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus
- What is being tested?
- EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Histologically confirmed solid tumor (e.g., melanoma, RCC, NSCLC).
- Currently receiving ICIs (such as but not limited to nivolumab, pembrolizumab, ipilimumab)
- Pruritus that is either:
- Refractory: Persistent pruritus despite standard treatment (e.g., antihistamines, corticosteroids).
- New-onset: Developing after initiation of ICIs or targeted therapies.
- ECOG performance status 0-2.
- Willingness to comply with study procedures and provide informed consent.
Who cannot join
- History of severe allergic reactions to Aprepitant.
- Uncontrolled or severe dermatologic conditions unrelated to cancer therapy.
- Use of NK1R antagonists within 4 weeks before study entry.
- Concurrent use of medications that strongly interact with Aprepitant.
- Concurrent use of medications that may influence pruritus manifestation (e.g steroids or antihistamines) . Note, Regular treatment with such medications prior to the appearance of pruritus, and or pruritus appearing despite such regular treatment, will not disqualify you from participating in the study
- Uncontrolled infection or significant comorbidities.
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gal Markel Director of Davidoff cancer center, deputy CEO RMC, Professor contact
About this study
Official title: Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus: Pilot Study in Solid Cancer Patients
Pruritus, commonly known as itching, is an unpleasant sensation that triggers the urge to scratch, which may provide temporary relief. Pruritus can be intermittent or persistent, localized or widespread, and may be associated with medication use. Chronic pruritus, defined as lasting more than six weeks, can significantly affect sleep and quality of life.
Dermatologic toxicities are among the most common immune-related adverse events (irAEs), reported in 43-45% of patients receiving ipilimumab and approximately 34% of those treated with nivolumab or pembrolizumab. Combination therapies (ipilimumab+ nivolumab or pembrolizumab) tend to elevate the incidence of potential irAEs to 41%. These toxicities typically emerge within the first few weeks of treatment, though delayed-onset cases have been documented. Cutaneous irAEs occur more rapidly in patients receiving combination therapy compared to anti-PD1 monotherapy.
Read more
Pruritus is one of the most frequently observed cutaneous irAEs. Current treatments for pruritus are often inadequate, leaving many patients suffering from persistent and debilitating symptoms. Despite available therapies, a significant number of individuals continue to experience chronic itch that negatively impacts their quality of life. Substance P (SP) functions as a neurotransmitter and neuromodulator in the central and peripheral nervous systems of mammals. It is produced by both neuronal and non-neuronal cells and plays a role in various physiological responses, including nausea, depression, vomiting, pain, neurogenic inflammation, and, more recently, pruritus. SP exerts its biological effects primarily through neurokinin receptors (NKRs), also known as tachykinin receptors. When SP binds to NK1R in the skin, it triggers mast cell degranulation, leading to the release of pruritogenic and proinflammatory mediators such as histamine, interferon-γ, leukotriene B4, vascular endothelial growth factor (VEGF), and nerve growth factor (NGF). This results in vasodilation and neurogenic inflammation, manifesting clinically as pruritus, erythema, and edema. NK1R antagonists are a class of drugs with antiemetic, antidepressant, anxiolytic, and antipruritic properties, though they have not been effective as analgesics in humans. These drugs act centrally by crossing the blood-brain barrier and selectively blocking NK1R activation by SP in the central nervous system, particularly in vomiting centers. Aprepitant has also demonstrated efficacy in treating pruritus induced by anticancer therapies.
This study is a pilot, single-center open label study evaluating the safety and efficacy of single course of EMEND® (aprepitant) capsules (80mg +125mg) in treating pruritus (new onset and/or refractory) induced by immune checkpoint inhibitors in patients with solid tumors.
- Conditions
- Pruritus
- Being tested
- EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd.
- Keywords
- pruritus, immune checkpoint inhibitors
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd.Drug
Total Treatment Duration: 1 cycle (1 administration of EMEND® capsules)
- Frequency: Patients will take EMEND® capsules at the start of new ICI.
- Dosing Schedule:
- Day 1: EMEND® 125 mg, taken orally 1-2 hours before ICI administration.
- Day 2: EMEND® 80 mg, taken orally in the morning.
- Day 3: EMEND® 80 mg, taken orally in the morning. During the study period (12 weeks), participant must refrain from using any medications that could potentially interfere with the study's assessment of pruritus symptoms (e.g steroids, antihistamines)
Follow-up 1(7 days after the first capsule of Aprepitant): 12-PSS, safety assessment, QLQ-C30 Follow-up 2: 12-PSS, safety assessment Follow-up 3: 12-PSS, safety assessment Follow-up 4: 12-PSS, QLQ-C30, safety assessment Extended Follow-up: Recurrence of pruritus, long-term safety monitoring, QLQ-C30
| Study group | Role | What they receive |
|---|---|---|
| 1 cycle of EMEND® capsules administration | Experimental | 1 cycle (1 administration of EMEND® capsules)
* Frequency: Patients will take EMEND® capsules at the start of new ICI.
* Dosing Schedule:
* Day 1: EMEND® 125 mg, taken orally 1-2 hours before ICI administration.
* Day 2: EMEND® 80 mg, taken orally in the morning.
* Day 3: EMEND® 80 mg, taken orally in the morning 7 days after the first capsule of Aprepitant- 12-PSS, safety assessment, QLQ-C30 Follow-up 2- 12-PSS, safety assessment Follow-up 3- 12-PSS, safety assessment Follow-up 4- 12-PSS, QLQ-C30, safety assessment, review of rescue medication use Extended Follow-up- Recurrence of pruritus, long-term safety monitoring, QLQ-C30 Receives: Drug: EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response is defined as 6 points reduction of pruritus intensity compared to the baseline value.
score interpretation: mild (3-6), moderate (7-11), or severe (12-22). higher scores indicate severe pruritus.
Measured: 12-Item Pruritus Severity Scale (12-PSS) score over a 12 weeks period, at baseline, every 7 days periprocedural for 4 weeks, and up to 12 weeks
Secondary outcomes (1)
Duration of pruritus relieving: the time from pruritus effective relief to 12-PSS score increase
Measured: baseline and up to 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start30 May 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Markel, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931119
- Sponsor's protocol ID
- 0173-25-RMC
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus: Pilot Study in Solid Cancer Patients
- ClinicalTrials.gov ID
- NCT06931119
- Acronym / sponsor ID
- 0173-25-RMC
- Conditions
- Pruritus
- Keywords
- pruritus, immune checkpoint inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pruritus, commonly known as itching, is an unpleasant sensation that triggers the urge to scratch, which may provide temporary relief. Pruritus can be intermittent or persistent, localized or widespread, and may be associated with medication use. Chronic pruritus, defined as lasting more than six weeks, can significantly affect sleep and quality of life.
Dermatologic toxicities are among the most common immune-related adverse events (irAEs), reported in 43-45% of patients receiving ipilimumab and approximately 34% of those treated with nivolumab or pembrolizumab. Combination therapies (ipilimumab+ nivolumab or pembrolizumab) tend to elevate the incidence of potential irAEs to 41%. These toxicities typically emerge within the first few weeks of treatment, though delayed-onset cases have been documented. Cutaneous irAEs occur more rapidly in patients receiving combination therapy compared to anti-PD1 monotherapy.
Pruritus is one of the most frequently observed cutaneous irAEs. Current treatments for pruritus are often inadequate, leaving many patients suffering from persistent and debilitating symptoms. Despite available therapies, a significant number of individuals continue to experience chronic itch that negatively impacts their quality of life. Substance P (SP) functions as a neurotransmitter and neuromodulator in the central and peripheral nervous systems of mammals. It is produced by both neuronal and non-neuronal cells and plays a role in various physiological responses, including nausea, depression, vomiting, pain, neurogenic inflammation, and, more recently, pruritus. SP exerts its biological effects primarily through neurokinin receptors (NKRs), also known as tachykinin receptors. When SP binds to NK1R in the skin, it triggers mast cell degranulation, leading to the release of pruritogenic and proinflammatory mediators such as histamine, interferon-γ, leukotriene B4, vascular endothelial growth factor (VEGF), and nerve growth factor (NGF). This results in vasodilation and neurogenic inflammation, manifesting clinically as pruritus, erythema, and edema. NK1R antagonists are a class of drugs with antiemetic, antidepressant, anxiolytic, and antipruritic properties, though they have not been effective as analgesics in humans. These drugs act centrally by crossing the blood-brain barrier and selectively blocking NK1R activation by SP in the central nervous system, particularly in vomiting centers. Aprepitant has also demonstrated efficacy in treating pruritus induced by anticancer therapies.
This study is a pilot, single-center open label study evaluating the safety and efficacy of single course of EMEND® (aprepitant) capsules (80mg +125mg) in treating pruritus (new onset and/or refractory) induced by immune checkpoint inhibitors in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 cycle of EMEND® capsules administration | Experimental | Drug: EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd.1 cycle (1 administration of EMEND® capsules) * Frequency: Patients will take EMEND® capsules at the start of new ICI. * Dosing Schedule: * Day 1: EMEND® 125 mg, taken orally 1-2 hours before ICI administration. * Day 2: EMEND® 80 mg, taken orally in the morning. * Day 3: EMEND® 80 mg, taken orally in the morning 7 days after the first capsule of Aprepitant- 12-PSS, safety assessment, QLQ-C30 Follow-up 2- 12-PSS, safety assessment Follow-up 3- 12-PSS, safety assessment Follow-up 4- 12-PSS, QLQ-C30, safety assessment, review of rescue medication use Extended Follow-up- Recurrence of pruritus, long-term safety monitoring, QLQ-C30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Histologically confirmed solid tumor (e.g., melanoma, RCC, NSCLC).
- Currently receiving ICIs (such as but not limited to nivolumab, pembrolizumab, ipilimumab)
- Pruritus that is either:
- Refractory: Persistent pruritus despite standard treatment (e.g., antihistamines, corticosteroids).
Key exclusion criteria (7 listed)
- History of severe allergic reactions to Aprepitant.
- Uncontrolled or severe dermatologic conditions unrelated to cancer therapy.
- Use of NK1R antagonists within 4 weeks before study entry.
- Concurrent use of medications that strongly interact with Aprepitant.
- Concurrent use of medications that may influence pruritus manifestation (e.g steroids or antihistamines) . Note, Regular treatment with such medications prior to the appearance of pruritus, and or pruritus appearing despite such regular treatment, will not disqualify you from participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd.Total Treatment Duration: 1 cycle (1 administration of EMEND® capsules) * Frequency: Patients will take EMEND® capsules at the start of new ICI. * Dosing Schedule: * Day 1: EMEND® 125 mg, taken orally 1-2 hours before ICI administration. * Day 2: EMEND® 80 mg, taken orally in the morning. * Day 3: EMEND® 80 mg, taken orally in the morning. During the study period (12 weeks), participant must refrain from using any medications that could potentially interfere with the study's assessment of pruritus symptoms (e.g steroids, antihistamines) Follow-up 1(7 days after the first capsule of Aprepitant): 12-PSS, safety assessment, QLQ-C30 Follow-up 2: 12-PSS, safety assessment Follow-up 3: 12-PSS, safety assessment Follow-up 4: 12-PSS, QLQ-C30, safety assessment Extended Follow-up: Recurrence of pruritus, long-term safety monitoring, QLQ-C30 | Drug | 1 cycle of EMEND® capsules administration |
Primary outcome
Response is defined as 6 points reduction of pruritus intensity compared to the baseline value.
Time frame: 12-Item Pruritus Severity Scale (12-PSS) score over a 12 weeks period, at baseline, every 7 days periprocedural for 4 weeks, and up to 12 weeks
score interpretation: mild (3-6), moderate (7-11), or severe (12-22). higher scores indicate severe pruritus.
1 secondary outcome
Duration of pruritus relieving: the time from pruritus effective relief to 12-PSS score increase
Time frame: baseline and up to 12 weeks post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gal Markel Director of Davidoff cancer center, deputy CEO RMC, Professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd. in people with Pruritus, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gal Markel Director of Davidoff cancer center, deputy CEO RMC, Professor (972-3-937-7990, galma4@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response is defined as 6 points reduction of pruritus intensity compared to the baseline value. (time frame: 12-Item Pruritus Severity Scale (12-PSS) score over a 12 weeks period, at baseline, every 7 days periprocedural for 4 weeks, and up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.