Renal Cell CancerPhase 2NCT05263609
Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib
A Phase 2 study testing Axitinib and Pembrolizumab in people with Renal Cell Cancer, run by University of Oklahoma.
Trial summary
The purpose of this research is to test the response of study participants' tumor to pembrolizumab alone, and in combination with axitinib, and to see what effects (good and bad) these drugs have on patients with advanced kidney cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Cell Cancer
- What is being tested?
- Axitinib and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of consent.
- ECOG performance status ≤1 (Appendix A) within 28 days prior to registration.
- Participants must have histologically or cytologically confirmed clear-cell or non-clear cell renal cell carcinoma.
- Presence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.137.
- Both previously untreated and treated patients will be eligible for participation with no limit on number of prior lines of therapy. Prior therapy with checkpoint inhibitors and/or axitinib for advanced disease is not allowed. Patients who have received treatment with prior checkpoint inhibitors (anti-PD-1/L1 or anti- CTLA-4) or VEGF receptor tyrosine kinase inhibitors in neoadjuvant/adjuvant setting are eligible for inclusion if time from treatment discontinuation to disease recurrence is more than 1 year.
- Adequately controlled blood pressure (BP), with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before the Cycle 1/Day 1.
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- Willingness of the patient to undergo mandatory fresh tumor biopsy on study unless determined medically unsafe or not feasible by the treating investigator. If a target lesion is biopsied at screening, this lesion must be followed as non-target lesion after the biopsy unless it is the patient's only target lesion.
- Participants must have normal organ and marrow function as defined below within 42 days prior to first study treatment
- A female participant is eligible to participate if they are not pregnant (negative urine or serum pregnancy test within 42 days prior to registration), not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow tcontraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- A male participant must agree to use contraception as of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
Who cannot join
- Participants who have had prior systemic checkpoint inhibitors (anti-PD-1/L1 or anti-CTLA-4) and/or axitinib for the management of metastatic RCC.
- Participants who have had any type of anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy, small molecule kinase inhibitor or chemotherapy) within 2 weeks prior to enrollment on the study.
- Radiotherapy for RCC within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms.
- Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to ≤ grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events CTCAE version v5.0) or baseline before administration of study drug38 with the exception of alopecia or grade 2 fatigue.
- Participants who are receiving systemic immunosuppressive medications within 2 weeks of first study dose, including but not limited to: prednisone, dexamethasone, cyclosporin, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor (TNF) agents
- Treatment with short term (<7 days), or low-dose systemic immunosuppressant medications (≤ 10 mg prednisone/day equivalent) within 2 weeks of first study dose is permitted.
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- Patients with adrenal insufficiency on physiologic replacement doses of steroids (≤ 10 mg prednisone equivalent) may be enrolled.
- The use of inhaled, topical, ocular or intra-articular corticosteroids and mineralocorticoids are allowed for other non-RCC co-morbidities.
- Any active or recent history (within 6 months of first study dose) of autoimmune disease or syndrome that requires systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications.
- Patients with low risk disorders, such as vitiligo, controlled type I diabetes mellitus, hypo- or hyperthyroid disease, or surgical adrenal insufficiency requiring hormone replacement therapy, are permitted to enroll. Discuss with PI any additional disorders not on this list that may qualify.
- Participants with known untreated or symptomatic metastases to the brain, spinal cord or leptomeninges. Patients may be eligible if stable intracranial disease for at least 4 weeks before first study treatment as documented by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging and if no ongoing requirement for steroids.
- Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening ECG > 480 msec.
- Bleeding or thrombotic disorders or patients at risk for severe hemorrhage. Gastrointestinal malabsorption, gastrointestinal anastomosis, fistula, or any other condition that might affect the absorption of axitinib.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or axitinib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known active or chronic hepatitis B infection (defined as having a positive hepatitis B surface antigen (HBsAg) test at screening).
- Patient with past or resolved hepatitis B infection (defined as having a negative HBsAg test and positive antibody to hepatitis B core antigen test) are eligible. Hepatitis B viral DNA must be obtained in patients with positive hepatitis B core antibody prior to first treatment start.
- Patients with active/chronic viral hepatitis C are ineligible because of the potential for pharmacokinetic interactions.
- Patients with positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
- Known HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions and an increased risk of lethal infections when treated with immunosuppressive therapy for immune related adverse events.
- Administration of a live vaccine or live-attenuated vaccine within 30 days of first dose of study treatment. Administration of killed vaccine is allowed.
- Receipt of therapeutic oral or IV antibiotics within 2 weeks of first study treatment. Patients receiving routine antibiotic prophylaxis (for dental extractions/procedures) are eligible. Empiric antibiotics given without subsequent proof of infection will not be counted as ineligible.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Prior allogenic stem cell or solid organ transplant.
- Other malignancies with the exception of those with negligible risk of metastases or death in view of the treating investigator and/or treated with expected curative outcome. Examples of (but not limited to) permitted treated cancers: carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma not requiring current therapy.
About this study
Official title: Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib in Metastatic Renal Cell Cancer: A Response Adapted Study (OPTIMAX)
The purpose of this research is to test the response of study participants' tumor to pembrolizumab alone, and in combination with axitinib, and to see what effects (good and bad) these drugs have on patients with advanced kidney cancer.
Read the detailed description
Patients will receive infusions of pembrolizumab. After an MRI or CT scan to determine how the tumor is responding to the drug, the patient will either continue receiving infusions of pembrolizumab alone, or receive axitinib in addition to pembrolizumab. The patient will also need to provide a biopsy of your tumor around the time the imaging scan is taken and need to come to the clinic around every three weeks during treatment. At the clinic visits, we will also do lab tests and imaging.
- Conditions
- Renal Cell Cancer
- Being tested
- Axitinib, Pembrolizumab
- Keywords
- axitinib, pembrolizumab, metastatic renal cell cancer, renal cell cancer
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
If pembrolizumab infusions alone do not reduce the patient's tumor size by at least 60%,the patient will be placed in Arm B and start axitinib in addition to continuing pembrolizumab therapy (see Arm B).
PembrolizumabDrug
If pembrolizumab results in a reduction in tumor size that is greater than 60%, the patient will be placed in Arm A and continue pembrolizumab infusions (see Arm A).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A (CR/oPR on pembrolizumab monotherapy):
Patients will continue pembrolizumab monotherapy if CR/oPR on initial treatment with pembrolizumab monotherapy. If CR/oPR persists at 8 cycles (24 weeks) after assignment on arm A, pembrolizumab break will commence. Patients will be monitored for disease progression with imaging every 9 weeks (+/- 1 week). If patients develop progression, pembrolizumab will be resumed and continued until subsequent PD. At that point, axitinib may be added to pembrolizumab as part of the study or patients may discontinue study treatment per the treating investigator's discretion. Receives: Drug: Pembrolizumab |
| Arm B | Experimental | Arm B (sPR/SD/PD):
Patients with sPR, SD or PD after 6 cycles of pembrolizumab monotherapy will be started on axitinib in addition to continuing pembrolizumab. If patients develop subsequent PD, treatment will be discontinued. If the subsequent scans show SD/PR/CR, the combination treatment will be continued until PD or unacceptable toxicity. Receives: Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patient Response
To catalogue the number and proportion of patients with persistence of complete response or optimal partial response at 1 year after the discontinuation of pembrolizumab
Measured: 2 year
Objective Response Rate After Axitinib
To assess the objective response rate after addition of axitinib in patients with a suboptimal partial response, stable disease or progressive disease on pembrolizumab monotherapy alone.
Measured: 2 year
Secondary outcomes (4)
Objective Response Rate after Pembrolizumab
To determine the objective response rate (ORR: CR +oPR + sPR) after 6 cycles of primary treatment with pembrolizumab
Measured: 2 year
Duration of Response
To determine duration of CR or oPR
To determine progression-free survival (PFS) from pembrolizumab initiation
To determine treatment-free survival (TFS) from pembrolizumab discontinuation
To assess safety and toxicity according to NCI CTCAE v5
Measured: 2 year
Overall Survival
To determine overall survival (OS) from pembrolizumab initiation
Measured: 2 year
Proportion of patients that experience toxicity
To assess safety and toxicity according to NCI CTCAE v5 on pembrolizumab monotherapy
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: PI left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Pfizer
- Responsible party
- Sponsor
- Investigators
- Abhishek Tripathi, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263609
- Sponsor's protocol ID
- OU-SCC-OPTIMAX
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2022
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib in Metastatic Renal Cell Cancer: A Response Adapted Study (OPTIMAX)
- ClinicalTrials.gov ID
- NCT05263609
- Acronym / sponsor ID
- OU-SCC-OPTIMAX
- Conditions
- Renal Cell Cancer
- Keywords
- axitinib, pembrolizumab, metastatic renal cell cancer, renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Pfizer
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Mar 2022 (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 purpose of this research is to test the response of study participants' tumor to pembrolizumab alone, and in combination with axitinib, and to see what effects (good and bad) these drugs have on patients with advanced kidney cancer.
Detailed description
Patients will receive infusions of pembrolizumab. After an MRI or CT scan to determine how the tumor is responding to the drug, the patient will either continue receiving infusions of pembrolizumab alone, or receive axitinib in addition to pembrolizumab. The patient will also need to provide a biopsy of your tumor around the time the imaging scan is taken and need to come to the clinic around every three weeks during treatment. At the clinic visits, we will also do lab tests and imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PembrolizumabArm A (CR/oPR on pembrolizumab monotherapy): Patients will continue pembrolizumab monotherapy if CR/oPR on initial treatment with pembrolizumab monotherapy. If CR/oPR persists at 8 cycles (24 weeks) after assignment on arm A, pembrolizumab break will commence. Patients will be monitored for disease progression with imaging every 9 weeks (+/- 1 week). If patients develop progression, pembrolizumab will be resumed and continued until subsequent PD. At that point, axitinib may be added to pembrolizumab as part of the study or patients may discontinue study treatment per the treating investigator's discretion. |
| Arm B | Experimental | Drug: AxitinibArm B (sPR/SD/PD): Patients with sPR, SD or PD after 6 cycles of pembrolizumab monotherapy will be started on axitinib in addition to continuing pembrolizumab. If patients develop subsequent PD, treatment will be discontinued. If the subsequent scans show SD/PR/CR, the combination treatment will be continued until PD or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years at the time of consent.
- ECOG performance status ≤1 (Appendix A) within 28 days prior to registration.
- Participants must have histologically or cytologically confirmed clear-cell or non-clear cell renal cell carcinoma.
- Presence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.137.
- Both previously untreated and treated patients will be eligible for participation with no limit on number of prior lines of therapy. Prior therapy with checkpoint inhibitors and/or axitinib for advanced disease is not allowed. Patients who have received treatment with prior checkpoint inhibitors (anti-PD-1/L1 or anti- CTLA-4) or VEGF receptor tyrosine kinase inhibitors in neoadjuvant/adjuvant setting are eligible for inclusion if time from treatment discontinuation to disease recurrence is more than 1 year.
Key exclusion criteria (25 listed)
- Participants who have had prior systemic checkpoint inhibitors (anti-PD-1/L1 or anti-CTLA-4) and/or axitinib for the management of metastatic RCC.
- Participants who have had any type of anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy, small molecule kinase inhibitor or chemotherapy) within 2 weeks prior to enrollment on the study.
- Radiotherapy for RCC within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms.
- Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to ≤ grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events CTCAE version v5.0) or baseline before administration of study drug38 with the exception of alopecia or grade 2 fatigue.
- Participants who are receiving systemic immunosuppressive medications within 2 weeks of first study dose, including but not limited to: prednisone, dexamethasone, cyclosporin, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor (TNF) agents
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 |
|---|---|---|
| AxitinibIf pembrolizumab infusions alone do not reduce the patient's tumor size by at least 60%,the patient will be placed in Arm B and start axitinib in addition to continuing pembrolizumab therapy (see Arm B). | Drug | Arm B |
| PembrolizumabIf pembrolizumab results in a reduction in tumor size that is greater than 60%, the patient will be placed in Arm A and continue pembrolizumab infusions (see Arm A). | Drug | Arm A |
Primary outcome
Proportion of Patient Response
Time frame: 2 year
To catalogue the number and proportion of patients with persistence of complete response or optimal partial response at 1 year after the discontinuation of pembrolizumab
Objective Response Rate After Axitinib
Time frame: 2 year
To assess the objective response rate after addition of axitinib in patients with a suboptimal partial response, stable disease or progressive disease on pembrolizumab monotherapy alone.
4 secondary outcomes
Objective Response Rate after Pembrolizumab
Time frame: 2 year
Duration of Response
Time frame: 2 year
Overall Survival
Time frame: 2 year
Proportion of patients that experience toxicity
Time frame: 2 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- 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. This study is not recruiting at the moment.
Abhishek Tripathi, MD principal investigator
Stephenson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axitinib and Pembrolizumab in people with Renal Cell Cancer, run by University of Oklahoma.
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 10 inclusion and 25 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: withdrawn, as of the sponsor's last update on 2 Aug 2022. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patient Response (time frame: 2 year). 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 2 Aug 2022.