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Metastatic Renal Cell CarcinomaPhase 2SPARCCNCT07123090

A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma

A Phase 2 study testing Sasanlimab, Palbociclib and Axitinib in people with Metastatic Renal Cell Carcinoma and Metastatic Renal Cancer, run by Stephanie Berg at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sasanlimab, Palbociclib and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
24 Nov 2025to 1 Apr 2028
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

  • Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible.
  • a. For tRCC please refer to the following for eligibility definitions:
  • i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable.
  • ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded.
  • b. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides from a primary or metastatic tumor resection or biopsy) can be provided if the following criteria are met:
  • i. The biopsy or resection was performed within 1 year of registration AND
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  • ii. The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and registration onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides (10 minimum) will be acceptable
  • c. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided as per documented regulations, then 15 unstained slides (10 minimum) will be acceptable.
  • Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease.
  • Age ≥ 18 years.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
  • Normal organ and marrow function as defined below:
  • a. Absolute neutrophil count ≥1.5×109/L
  • b. Platelets ≥100×109/L
  • c. Hemoglobin ≥9g/dL (RBC transfusions allowed)
  • d. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) with the following exception: patients with known Gilbert disease should have a total serum bilirubin ≤ 3 x ULN
  • e. AST(SGOT)/ALT(SGPT) ≤1.5 × ULN
  • f. Creatinine clearance ≥30 mL/min according to the CKD-EPI equation. (APPENDIX C)
  • g. Urine protein <1+ by urinalysis; If ≥1+ protein or otherwise suggestive of any proteinuria above a trace amount (per local institutional standards), a random urine protein and creatinine ratio (UPCR) should be collected. A 24-hour urine collection can also be utilized for direct measurement. When multiple modalities are used, the 24-hour urine measurement takes precedence over the random UPCR; refer to section 6.2 for further guidance.
  • Women of child-bearing potential and men must agree to use adequate contraception (intrauterine device or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. A negative pregnancy serum test should be obtained within 7 days of therapy initiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. Participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of sasanlimab, axitinib and palbociclib administration.
  • Ability to swallow oral medications.
  • Ability to understand and willingness to sign a written informed consent document.

Who cannot join

  • Treatment with the following prior therapies:
  • a. Prior systemic therapy for advanced or metastatic RCC.
  • b. Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred within 12 months of last dose of such therapy. Treatment with an immune checkpoint inhibitor in the adjuvant setting is allowed providing more than 12 months have elapsed since last dose or completion of therapy.
  • c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways).
  • d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).
  • Prior therapy with any CDK4/6 inhibitor.
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  • Participants with untreated brain metastases. Participants with metastatic CNS tumors may participate in this trial, if the participant is ≥ 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy >10 mg/day prednisone equivalents. A repeat MRI or CT brain to show stability is required.
  • Wide field radiation therapy ≤ 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic non-target lesion(s) is permitted if completed at least 48hrs prior to patient registration.
  • Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1.
  • Major surgery/surgical procedures within the past 4 weeks prior to registration.
  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease - also see 3.2.22, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Current or prior use of immunosuppressive medication within 7 days prior to registration, except the following:
  • a. Intranasal, inhaled, topical steroids, or local steroid injections (eg. intra-articular injection).
  • b. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent.
  • c. Steroids as premedication for hypersensitivity reactions (eg. CT scan premedication).
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3) or any history of anaphylaxis.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment are eligible.
  • Vaccination within 4 weeks of the first dose of sasanlimab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza or shingles vaccines). Note, the COVID19 vaccine is not a live vaccine and permitted.
  • Grade ≥3 hemorrhage within 4 weeks of registration.
  • Patient with active systemic bacterial infection (requiring IV antibiotics at the time of initiating study treatment), fungal infection, or detectable viral infection. Patients with known viral infection (such as HIV) are excluded given the potential for interactions between antiretroviral agents and palbociclib and axitinib, and the potential for increased risk of life-threatening infection with therapy that is myelosuppressive. If patients are not known to have HIV, a HIV test is required prior to registration.
  • Patients with known Hepatitis B or Hepatitis C infection are excluded only if there is evidence of active infection (detectable Hepatitis B surface antigen, detectable HBV DNA, or detectable Hepatitis C RNA).
  • Prior allogenic or autologous stem cell or any solid organ transplant.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Participants who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant. Therapeutic use of low molecular weight heparin and factor Xa inhibitors (eg. apixaban, rivaroxaban) is permitted.
  • Other malignancy diagnosed within 2 years of treatment start unless negligible risk of metastases or death according to the investigator (included but not limited to 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, or other malignancy not deemed to impact patients 5-year life expectancy).
  • Has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), myocarditis, sudden cardiac arrest.
  • Has had any major cardiovascular event within 6 months prior to treatment start, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event or New York Heart Association Class III or IV heart failure.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2 or history of long QTC syndrome. Any history of myocarditis.
  • History of interstitial lung disease or other restrictive lung disease, as well as history of symptomatic respiratory condition considered clinically significant by the investigator. Individuals with a history of radiotherapy to the thorax and any history of pneumonitis will be excluded.
  • Current or past tobacco users with a history of cigarette smoking greater than 30 pack-yrs (i.e., # of packs of cigarettes smoked per day × # of years patient has smoked > 30).
  • Participants with a known hypersensitivity to the study compounds or to its excipients.
  • Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors, including their administration within 7 days prior to treatment start (eg. Grapefruit juice or grapefruit/grapefruit-related citrus fruits [eg. Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, , clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan). The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.
  • Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, including their administration within 14 days prior to treatment start (eg. Phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, 23albociclib, clevidipine, St John's wort).
  • Participants who have taken herbal medications within 7 days prior to treatment start. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
  • Females that are pregnant or breastfeeding.
  • Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephanie Berg, DO contact

617-632-6328

stephaniea_berg@dfci.harvard.edu

Bradley McGregor, MD contact

1-877-DF-TRIAL

Bradley_McGregor@DFCI.HARVARD.EDU

United States2 sites, 2 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

    Stephanie Berg, DO, 617-632-6328, stephaniea_berg@dfci.harvard.edu

    Stephanie Berg, DO

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Stephanie Berg, DO, 617-632-6328, stephaniea_berg@dfci.harvard.edu

    Stephanie Berg, DO

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).

The name of the study drugs involved in this research study is:

  • Sasanlimab (a type of monoclonal antibody)
  • Palbociclib (a type of kinase inhibitor)
  • Axitinib (a type of Vascular endothelial growth factor inhibitor)
Read the detailed description

This single arm, Phase 2 study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).

The U.S. Food and Drug Administration (FDA) has not approved sasanlimab or palbociclib as a treatment option for ccRCC or tRCC.

The U.S. FDA has approved axitinib as a treatment option for ccRCC.

The U.S. FDA has not approved the combination of sasanlimab, axitinib, and palbociclib for ccRCC or tRCC.

The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, imaging scans, and electrocardiograms (ECGs).

It is expected that about 25 people will take part in this research study.

Pfizer, is supporting this research study by providing funding and the study drugs, sasanlimab, palbociclib, and axitinib.

Being tested
Sasanlimab, Palbociclib, Axitinib
Keywords
Metastatic Renal Cell Carcinoma, Metastatic Renal Cancer, Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, Translocation Renal Cell Carcinoma, ccRCC, tRCC
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SasanlimabDrug

    Also called PF-06801591

    Recombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol

  • PalbociclibDrug

    Also called C24H29N7O2

    Cyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol

  • AxitinibDrug

    Also called C22H18N4OS

    Vascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care

Study groups in NCT07123090
Study groupRoleWhat they receive
Sasanlimab, Axitinib, and PalbociclibExperimentalA Bayesian dose-limiting toxicity plan will be employed per protocol with a monitoring time period of the first two cycles of therapy and starting after the first three participants have started protocol therapy. 25 enrolled participants will complete: * Baseline visit with assessments and imaging * Imaging every 8 weeks for 16 weeks, then every 12 weeks * Cycle 1 Through End of Treatment (28 day cycles): * Day 1: Predetermined dose of Sasanlimab 1x daily * Days 1 through 28: Predetermined dose of Axitinib 2x daily, * Days 8 through 28: Predetermined dose of Palbociclib 1x daily * End of treatment visit * Follow up every 6 months for 2 years after treatment discontinuation
Receives: Drug: Sasanlimab; Drug: Palbociclib; Drug: Axitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

    Measured: Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months

Secondary outcomes (5)

  1. Grade 3 or Higher Treatment-Related Adverse Event (AE) Rate

    The percentage of participants who experienced a grade 3 or higher treatment-related AE based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms. Treatment-related AEs are defined as those rated 'Possibly", "Probably", or "Definitely" related to any of the study drugs.

    Measured: AEs will be collected during study treatment, and participants will be followed for 90 days post last treatment administration, or until initiation of new cancer-directed treatment, up to 17 months.

  2. Complete Response Rate (CRR)

    CRR is defined as the percentage of participants achieving complete response (CR) based on RECIST 1.1 criteria. Per RECIST 1.1, CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and absence of new lesions.

    Measured: Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months

  3. Deep Partial Response Rate

    Deep partial response rate is defined as the percentage of participants achieving deep partial response based on RECIST 1.1. Deep partial response is defined as ≥80% reduction in target lesions by central review.

    Measured: Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months

  4. Median Progression-Free Survival (PFS)

    PFS based on Kaplan-Meier method is defined as the time from protocol treatment initiation to the earlier of progression or death due to any cause. Participants alive without PD are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

    Measured: Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months

  5. Median Overall Survival (OS)

    OS based on the Kaplan-Meier method is defined as the time from protocol treatment initiation to death due to any cause, or censored at date last known alive.

    Measured: Participants will be followed for survival every 6 months after treatment discontinuation, until death or for up to 2 years, whichever comes first. Treatment duration is up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start24 Nov 2025
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07123090
Sponsor's protocol ID
25-258
Acronym
SPARCC
Status last verified
Aug 2026
First submitted
8 Aug 2025
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sasanlimab, Palbociclib and Axitinib in people with Metastatic Renal Cell Carcinoma and Metastatic Renal Cancer, run by Stephanie Berg at 2 sites 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 22 inclusion and 36 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Stephanie Berg, DO (617-632-6328, stephaniea_berg@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07123090.

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 20 Aug 2026.

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