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Renal Cell CarcinomaPhase 2NCT06860386

Study of Adaptive Immunotherapy With VEGFR-TKI in Patients With Advanced RCC

A Phase 2 study testing Pembrolizumab and Axitinib in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a Phase II Clinical Trial that will evaluate the use of adaptive dosing of pembro-axi in patients with Metastatic Clear Cell Renal Cell Carcinoma (mccRCC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
25 Feb 2025to Feb 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unresectable advanced or metastatic Renal Cell Carcinoma (RCC) to include only predominant clear cell histology.
  • Age ≥ 18 years or older at time of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 within 28 days prior to registration.
  • Availability of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens, when available, and willingness of the subject to undergo fresh tumor biopsy prior to treatment initiation if archival tissue not available.
  • 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.
  • If there is only one target lesion, it should be followed as a target lesion regardless.
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  • The archival specimen must contain adequate viable tumor tissue.
  • The specimen may consist of a tissue block (preferred and should contain the highest grade of tumor) or at least 30 unstained serial sections. Fine needle aspiration/ biopsy, brushings, cell pellet from pleural effusion, bone lesion, bone marrow aspirate/biopsy are not acceptable.
  • Have had no prior systemic therapy (treatment naïve) for Metastatic Clear Cell Renal Cell Carcinoma (mccRCC). Prior neoadjuvant or adjuvant therapy received for localized ccRCC is not allowed.
  • Measurable disease as defined by Response Evaluation Criteria In Solid Tumors RECIST 1.1 within 28 days prior to registration.
  • Must demonstrate adequate hematological, hepatic and kidney organ function with all screening labs to be obtained within 28 days prior to first study treatment.
  • Females of childbearing potential must have a negative serum pregnancy test within 28 days prior to registration. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
  • Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 150 days after treatment discontinuation for females and 210 days after treatment discontinuation for males. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.
  • As determined by the enrolling physician or protocol designee, must have ability to comprehend and the willingness to sign written informed consent, and comply with study procedures for entire length of study to be eligible for study participation.
  • Patients with well-controlled Hepatitis B, Hepatitis C, or HIV will be considered eligible.

Who cannot join

  • Has had major surgery within 4 weeks and/or has received radiation therapy within 2 weeks prior to Cycle 1, Day 1 (C1D1).
  • Has received prior systemic anti-cancer therapy for RCC (e.g., VEGF/VEGFR, chemotherapy or mTOR-targeting agents). Note: Prior neoadjuvant/adjuvant therapy for ccRCC is acceptable if last dose was received more than 3 months from start of C1 D1.
  • Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema hypotension, bronchospasm, angioedema, or anaphylaxis) to axitinib or pembrolizumab.
  • Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to C1D1.
  • Note: Subjects with vitiligo, Sjögren's syndrome, Type 1 diabetes, or resolved childhood asthma/atopy will not be excluded from the study. Subjects requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded from the study. Subjects with hypothyroidism, or adrenal or pituitary insufficiency who are stable on hormone replacement will not be excluded from the study.
  • Has a known additional malignancy that has progressed or has required active treatment in the last 1 year. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy.
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  • Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to C1D1.
  • Has a history of (non-infectious) pneumonitis that required steroids in the past 6 months or current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection (e.g. HIV 1 and/or 2 antibodies), that is not well controlled.
  • Has a known history of Hepatitis B (e.g., Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (e.g., HCV RNA [qualitative] is detected), that is not well controlled.
  • Has a clinically significant gastrointestinal (GI) abnormality including: Malabsorption, total gastric resection, or any other condition that might affect the absorption of orally taken medication. Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy. Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation.
  • 12-lead ECG will be performed during screening. If the initial QTcF is found to be > 500 msec, two additional EKGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets eligibility in this regard.
  • Has a known history of any of the following cardiovascular conditions within 6 months of C1D1 of therapy:
  • Myocardial infarction
  • Unstable angina pectoris
  • Cardiac angioplasty or stenting
  • Coronary/peripheral artery bypass graft
  • Class III or IV congestive heart failure per New York Heart Association
  • Cerebrovascular accident or transient ischemic attack
  • Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg. Subjects with initial screening BP ≥160/90 mmHg can be treated with anti-hypertensive medication to achieve a well-controlled status and are eligible with reassessed SBP/DBP of < 150/95 mm Hg.
  • Has evidence of inadequate wound healing or active bleeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Study Assessing the Feasibility and Clinical Efficacy of Adaptive Immunotherapy Combination With VEGFR-TKI in Patients With Advanced Renal Cell Carcinoma

This is a Phase II Clinical Trial that will evaluate the use of adaptive dosing of pembro-axi in patients with Metastatic Clear Cell Renal Cell Carcinoma (mccRCC).

Being tested
Pembrolizumab, Axitinib
Keywords
Renal Cell Carcinoma
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.

  • PembrolizumabDrug

    Also called KEYTRUDA

    200 mg every 3 weeks IV infusion (Q3W + or -3 days)

  • AxitinibDrug

    Also called INLYTA

    5 mg twice daily (BID) by mouth

Study groups in NCT06860386
Study groupRoleWhat they receive
Adaptive Dosing pembro-axiExperimentalIn therapy naïve mccRCC patients, a standard dose of pembrolizumb will be given at 200 mg iv every 3 weeks, with axitinib given orally 5 mg twice daily. After 9 weeks, subjects will undergo the first response assessment as well as the therapy portion of the trial if they have 20% response per RECIST criteria. During adaptive dosing with pembro-axi, imaging is conducted every 9 weeks. Treatment is held until the tumor has returned to its baseline size or greater per RECIST 1.1, then restarted until a tumor reduction of at least 20% occurs. Therapy cycles on and off in this manner continue as the tumor shrinks and grows until confirmed progression of disease while on therapy.
Receives: Drug: Pembrolizumab; Drug: Axitinib

What is being measured

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

  1. Recruitment Rate Feasibility

    Measured as the percentage of eligible patients with a >20% tumor response who consent to participate in the adaptive therapy.

    Successful enrollment if at least 70% of eligible patients agree to participate in the adaptive therapy

    Measured: Up to 36 Months

  2. Progression Free Survival (PFS)

    Measured from the start of treatment until the point of disease progression or death from any cause.

    Measured: Up to 12 Months

Secondary outcomes (2)

  1. Persistent Disease Control

    Measured as the proportion of patients who complete adaptive therapy and do not requiring disease re-initiation for more than 12 months after therapy discontinuation.

    Measured: Up to 36 Months

  2. Overall Survival (OS)

    Measured as time from date of enrollment to death from any cause.

    Measured: Up to 36 Months

Timeline

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

  1. First posted6 Mar 2025
  2. Study start25 Feb 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionFeb 2028 (estimated)

Why it stopped: Funding unavailable

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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06860386
Sponsor's protocol ID
MCC-23473
Status last verified
Mar 2026
First submitted
4 Mar 2025
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hatoum F, Dyer B, Heiligh J, Poehlman T, Zhang J, Jameel G, Mizelle S, Patel A, Schneider A, Fazili A, Johnson JS, Miller JW, Roman Souza G, Mahmoud N, Gullapalli K, Kim Y, Spiess PE, Gatenby R, Anderson ARA, Chahoud J. A phase II study assessing the feasibility and clinical efficacy of adaptive immunotherapy combination with VEGFR-TKI in patients with advanced renal cell carcinoma. Future Oncol. 2026 Sep 10:1-9. doi: 10.1080/14796694.2026.2717069. Online ahead of print.

    PubMed 42719952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Axitinib in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 15 inclusion and 22 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: paused, as of the sponsor's last update on 6 Mar 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?

Results are not available in the source record.

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?

Recruitment Rate Feasibility (time frame: Up to 36 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?

On the ClinicalTrials.gov record for NCT06860386, which also lists 1 linked publication.

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 6 Mar 2026.

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