Renal Cell CarcinomaPhase 2PSI-ImmuneNCT07223424
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
A Phase 2 study testing nivolumab and pembrolizumab in people with Renal Cell Carcinoma and Non Small Cell Lung Cancer, run by Diwakar Davar at 1 site in United States.
Trial summary
The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma
- What is being tested?
- nivolumab and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to 30 Nov 2030
- Phase
- Phase 2
- 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
- Able to understand and willing to sign a written informed consent document.
- Able to read and write in English.
- Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.
- Prior and concurrent therapy criteria
- o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).
- Locally advanced or advanced/metastatic solid tumor for which nivolumab OR pembrolizumab is on-label.
Show all 16Show fewer
- NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR/MSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric/GEJ).
- NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR/MSI-H CRC, HCC, esophageal cancer, gastric/GEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).
- Cohort-specific criteria.
- Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.
- Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.
- Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.
- Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.
- NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced/metastatic melanoma, ccRCC, MSI-H/dMMR mCRC.
- NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).
- NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.
Who cannot join
- Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.
- Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and/or any of its excipients.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Danielle L Bednarz, RN, 4126231191, bednarzdl@upmc.edu
Amy Rose, RN, 4126478587, kennaj@upmc.edu
About this study
Official title: Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)
The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.
Read the detailed description
The development of SC nivolumab and SC pembrolizumab was intended to provide patients, physicians and health care systems compelling advantages to reduce the burden associated with ICI administration. However, despite the results of CheckMate 76K, Hillman Cancer Center utilization of SC nivolumab is poor. This study aims to formally assess, from the patients' perspective, whether SC administration of ICI agents is preferable to IV administration. Key secondary objectives include physician experience with SC vs. IV administration, cancer-related efficacy endpoints, and safety. Patients who are pending initiation of nivolumab monotherapy or nivolumab-based chemotherapy or targeted therapy combinations (Cohort A-1) will be enrolled. However, patients who are already receiving nivolumab or other ICI but are willing to be switched to nivolumab monotherapy or nivolumab-based combinations may be eligible to enroll in a separate cohort (Cohort B-1). US FDA has accepted a Biologics License Application from Merck for SC pembrolizumab for an FDA action date of 9/23/2025. Should SC pembrolizumab achieve FDA approval, we will aim to open 2 separate cohorts to evaluate patient preference for SC vs. IV pembrolizumab.
- Conditions
- Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Colo-rectal Cancer (dMMR/MSI-H CRC), Hepatocellular Carcinoma, Ulcerative Colitis
- Being tested
- nivolumab, pembrolizumab
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Melanoma, Colonic Neoplasms, Carcinoma, Hepatocellular, Colitis, Ulcerative, Esophageal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabDrug
Also called OPDIVO®
IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)
pembrolizumabDrug
Also called Keytruda®
IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous to IV | Active comparator | SC nivolumab (or pembrolizumab) x3 cycles followed by IV nivolumab (or pembrolizumab) x3 cycles. Receives: Drug: nivolumab; Drug: pembrolizumab |
| IV to Subcutaneous | Active comparator | IV nivolumab (or pembrolizumab) x3 cycles followed by SC nivolumab (or pembrolizumab) x3 cycles Receives: Drug: nivolumab; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference for Subcutaneous Nivolumab Treatment
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV nivolumab.
Measured: Up to 48 months
Preference for Subcutaneous Pembrolizumab Treatment
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV pembrolizumab.
Measured: Up to 48 months
Secondary outcomes (12)
Therapy Administration Satisfaction Questionnaire
Patient assessed satisfaction with SC vs. IV nivolumab (or pembrolizumab) using Therapy Administration Satisfaction Questionnaire (using TASQ-IV) in patients with locally advanced or advanced/metastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations.
Measured: Up to 48 months
Therapy Administration Satisfaction Questionnaire
Patient assessed satisfaction with SC vs. IV nivolumab (or pembrolizumab) using Therapy Administration Satisfaction Questionnaire (using TASQ-SC) in patients with locally advanced or advanced/metastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations.
Measured: Up to 48 months
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Patient reported HRQoL scores using the EORTC QLQ-C30 instrument. The categories/domains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale. Item scoring for functional items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores (all items) range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Measured: Screening Phase - Up to 28 days after signed consent
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Patient reported HRQoL scores using the EORTC QLQ-C30 instrument (30 items). The categories/domains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), and global health status and quality of life scale. Item scoring for functional and symptom items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Measured: At Day 1 of Treatment Cycle 3
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Patient reported HRQoL scores using the EORTC QLQ-C30 instrument (30 items). The categories/domains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), and global health status and quality of life scale. Item scoring for functional and symptom items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Measured: At Day 1 of Treatment Cycle 6
Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Changes in patient reported HRQoL scores using the EORTC QLQ-C30 instrument. The categories/domains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), and global health status and quality of life scale. Item scoring for functional and symptom items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
Measured: Up to 48 nmonths
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.
Measured: Screening Phase - Up to 28 days after signed consent
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.
Measured: At Day 1 of Treatment Cycle 3
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.
Measured: At Day 1 of Treatment Cycle 6
Change Health Related Quality of Life (HRQoL) - EQ-5D-5L
Change in patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.
Measured: Up to 48 months
Physician-defined TTNT
Physician-defined time to next therapy (TTNT) is defined as the period from the start of the treatment to the start of the next line of treatment.
Measured: Up to 48 months
Incidence of irAEs
Incidence of immune-related adverse events (irAEs) that result in a dose hold or delay in patients treated with either SC or IV nivolumab (or pembrolizumab) per Common Terminology Criteria for Adverse Events (CTCAE) guidelines v5
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start4 Nov 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diwakar Davar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diwakar Davar, University of Pittsburgh
- Investigators
- Diwakar J Davar, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223424
- Sponsor's protocol ID
- HCC 25-125
- Acronym
- PSI-Immune
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)
- ClinicalTrials.gov ID
- NCT07223424
- Acronym / sponsor ID
- PSI-Immune / HCC 25-125
- Conditions
- Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Colo-rectal Cancer (dMMR/MSI-H CRC), Hepatocellular Carcinoma, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Diwakar DavarUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 31 Oct 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.
The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.
Detailed description
The development of SC nivolumab and SC pembrolizumab was intended to provide patients, physicians and health care systems compelling advantages to reduce the burden associated with ICI administration. However, despite the results of CheckMate 76K, Hillman Cancer Center utilization of SC nivolumab is poor. This study aims to formally assess, from the patients' perspective, whether SC administration of ICI agents is preferable to IV administration. Key secondary objectives include physician experience with SC vs. IV administration, cancer-related efficacy endpoints, and safety. Patients who are pending initiation of nivolumab monotherapy or nivolumab-based chemotherapy or targeted therapy combinations (Cohort A-1) will be enrolled. However, patients who are already receiving nivolumab or other ICI but are willing to be switched to nivolumab monotherapy or nivolumab-based combinations may be eligible to enroll in a separate cohort (Cohort B-1). US FDA has accepted a Biologics License Application from Merck for SC pembrolizumab for an FDA action date of 9/23/2025. Should SC pembrolizumab achieve FDA approval, we will aim to open 2 separate cohorts to evaluate patient preference for SC vs. IV pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous to IV | Active comparator | Drug: nivolumab, Drug: pembrolizumabSC nivolumab (or pembrolizumab) x3 cycles followed by IV nivolumab (or pembrolizumab) x3 cycles. |
| IV to Subcutaneous | Active comparator | Drug: nivolumab, Drug: pembrolizumabIV nivolumab (or pembrolizumab) x3 cycles followed by SC nivolumab (or pembrolizumab) x3 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to understand and willing to sign a written informed consent document.
- Able to read and write in English.
- Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.
- Prior and concurrent therapy criteria
- o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).
Key exclusion criteria (3 listed)
- Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.
- Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and/or any of its excipients.
- Has had an allogenic tissue/solid organ transplant.
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 |
|---|---|---|
| nivolumabAlso: OPDIVO®IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W) | Drug | IV to Subcutaneous, Subcutaneous to IV |
| pembrolizumabAlso: Keytruda®IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W) | Drug | IV to Subcutaneous, Subcutaneous to IV |
Primary outcome
Preference for Subcutaneous Nivolumab Treatment
Time frame: Up to 48 months
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV nivolumab.
Preference for Subcutaneous Pembrolizumab Treatment
Time frame: Up to 48 months
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV pembrolizumab.
12 secondary outcomes
Therapy Administration Satisfaction Questionnaire
Time frame: Up to 48 months
Therapy Administration Satisfaction Questionnaire
Time frame: Up to 48 months
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: Screening Phase - Up to 28 days after signed consent
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: At Day 1 of Treatment Cycle 3
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: At Day 1 of Treatment Cycle 6
Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: Up to 48 nmonths
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: Screening Phase - Up to 28 days after signed consent
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: At Day 1 of Treatment Cycle 3
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: At Day 1 of Treatment Cycle 6
Change Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: Up to 48 months
Physician-defined TTNT
Time frame: Up to 48 months
Incidence of irAEs
Time frame: Up to 48 months
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Diwakar J Davar, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nivolumab and pembrolizumab in people with Renal Cell Carcinoma and Non Small Cell Lung Cancer, run by Diwakar Davar at 1 site in United States.
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 16 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Danielle L Bednarz, RN (4126231191, bednarzdl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference for Subcutaneous Nivolumab Treatment (time frame: Up to 48 months). The study lists 2 primary outcomes in all. 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 16 Apr 2026.