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Renal Cell CarcinomaPhase 2PANDORANCT04995016

Pembrolizumab and Axitinib as Neoadjuvant Therapy for Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

A Phase 2 study testing Pembrolizumab and Axitinib in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of pembrolizumab combined with axitinib as neoadjuvant therapy for locally advanced non-metastatic clear cell renal cell carcinoma. 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
18 participants
Where
1 siteChina
Study dates
20 Aug 2021to 20 Aug 2023
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

  • Patients with a renal mass consistent with a clinical stage >= T3Nx or TanyN+ or deemed unresectable by surgeon
  • Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor
  • The participant (or legally acceptable representative if applicable) provides written informed consent and the willingness and ability to comply with all aspects of the protocol
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Agree to collect tumor tissue, blood and other specimens required by this study and apply them to relevant studies
  • Important organs and bone marrow functions meet the following requirements: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet (PLT) ≥100×10^9/L, hemoglobin (HGB) ≥9g/dL;Liver function: serum total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 times ULN, serum albumin (ALB) ≥ 2.8g /dL. Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min
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  • Cardiac function met the following conditions: baseline electrocardiogram (ECG) had no evidence of PR prolongation or AV block
  • All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [beta-hCG]) at the screening visit and the baseline visit. A pregnancy test needs to be performed within 72 hours of the first dose of study drug. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation
  • Male subjects who are partners of women of childbearing potential must use a condom and their female partners of childbearing potential must use a highly effective method of contraception beginning at least 1 menstrual cycle prior to starting study drugs, throughout the entire study period, and for 120 days after the last dose of study drug, unless the male subjects are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile

Who cannot join

  • Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
  • Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
  • Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
  • Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment.
  • Subject is on any other form of immunosuppressive medication
  • Unable to swallow and retain orally administered medication
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  • Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other -Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
  • Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
  • Presence of active infection requiring systemic therapy
  • Corrected QT interval duration prolongation
  • History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; --History of Class III or IV congestive heart failure according to New York Heart Association classification
  • History of cerebrovascular accident within the past 6 months
  • Poorly controlled hypertension
  • History of untreated deep venous thrombosis
  • Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
  • Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of study treatment
  • Subject has received or will receive a live vaccine within 30 days before the first administration of study treatment

Trial locations and contacts

1 site in 1 country.

Bin HUO contact

+860228832 ext. 6610

huobin_doctor@icloud.com

China1 site

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin Municipality, 300211

Other trials in China

About this study

Official title: A Single-center, Non-randomized Controlled, Single-arm, Phase II Clinical Trial of Pembrolizumab and Axitinib as Neoadjuvant Therapy for Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of pembrolizumab combined with axitinib as neoadjuvant therapy for locally advanced non-metastatic clear cell renal cell carcinoma.

Read the detailed description

This study is design to prospectively investigate the safety and efficacy of pembrolizumab combined with axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid on days 1-21 combined with pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.

Being tested
Pembrolizumab, Axitinib
Keywords
Pembrolizumab, Axitinib, Neoadjuvant
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

    PD-1 inhibitor，Pembrolizumab 200mg IV, every 3 weeks.

  • AxitinibDrug

    Also called Inlyta

    Tyrosine kinase inhibitor，licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID.

Study groups in NCT04995016
Study groupRoleWhat they receive
Locally Advanced Non-metastatic Clear Cell Renal Cell CarcinomaExperimentalNeoadjuvant pembrolizumab plus axitinib
Receives: Drug: Pembrolizumab; Drug: Axitinib

What is being measured

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

  1. Major Pathologic Response (MPR)

    The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), MPR is defined as %RVT<10%

    Measured: 12 weeks

Secondary outcomes (5)

  1. Pathologic Complete Response (pCR)

    The residual tumor cells (% RVT) were calculated according to immune related pathologic response criteria (irPRC), pCR is defined as %RVT<0%

    Measured: 12 weeks

  2. Objective response rate (ORR)

    Rate of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and immune-related response criteria (IRC)

    Measured: 12 weeks

  3. Disease-free survival(DFS)

    DFS is defined as the time from treatment to recurrence of tumor or death

    Measured: Up to 24 months

  4. Overall survival(OS)

    OS is defined as the time from treatment to death

    Measured: Up to 24 months

  5. Incidence of treatment-related adverse events(AEs)

    To be assessed by CTCAE v5.0

    Measured: Up to 24 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 Aug 2021
  2. Study start20 Aug 2021 (estimated)
  3. Primary completion20 Aug 2022 (estimated)
  4. Study completion20 Aug 2023 (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
Model description
simon's two stage design
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995016
Sponsor's protocol ID
PANDORA 001
Acronym
PANDORA
Status last verified
Jul 2021
First submitted
30 Jul 2021
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 Tianjin Medical University Second Hospital at 1 site in China.

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 9 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. 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 China. 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?

Contact Bin HUO (+860228832 ext. 6610, huobin_doctor@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathologic Response (MPR) (time frame: 12 weeks). 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 NCT04995016.

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 Aug 2021.

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