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Renal Cell CarcinomaPhase 2NCT05485896

Neoadjuvant Therapy of Pembrolizumab Plus Lenvatinib in Advanced RCC

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Pembrolizumab plus Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
1 Jul 2022to 2 Sep 2024
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent;
  • Age ≥ 18 years and age ≤75years;
  • Patients with pathologically and radiographically confirmed clear cell renal cell carcinoma with clinical staging: cTanyN1Many, cTanyNanyM1, cT3-4NanyMany, and all visible lesions could be excised or ablation treated;
  • Enhanced imaging evaluation can be performed;
  • There are no suspected brain metastases;
  • The presence of measurable lesions was assessed according to RECISTv1.1 criteria;
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
  • Organ function level must meet the following requirements:
  • Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=1.5 ULN;
  • Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study;
  • The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up.

Who cannot join

  • Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors;
  • Previous or concurrent other malignancy;
  • Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1;
  • History of primary immunodeficiency;
  • Active, known or suspected autoimmune diseases;
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
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  • Pregnant or lactating female patients;
  • Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
  • Have a clear history of active tuberculosis;
  • Participating in other clinical researchers;
  • Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
  • Uncontrolled concurrent diseases, including but not limited to:
  • HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]); Patients with active bleeding or new thrombotic disease.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changyi Quan

    Tianjin, Tianjin Municipality, 300211

Other trials in China

About this study

Official title: A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cell Carcinoma

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's surgery.

Read the detailed description

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment is beneficial to operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).

Being tested
Pembrolizumab plus Lenvatinib
Keywords
Pembrolizumab; Lenvatinib; Advanced 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.

  • Pembrolizumab plus LenvatinibDrug

    Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).

Study groups in NCT05485896
Study groupRoleWhat they receive
Advanced RCC (Locally advanced, regional LN invaded, or M1-NED)ExperimentalPatients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. In addition, 17 cycles' Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).
Receives: Drug: Pembrolizumab plus Lenvatinib

What is being measured

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

  1. Tumor responses

    All patients had imaging (enhanced CT, enhanced MRI or both ) before and after treatment to evaluate radiographic response within the primary tumor and venous tumor thrombus by using RECIST (Response Evaluation Criteria in Solid Tumors)

    Measured: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).

  2. Adverse events

    Adverse events were monitored throughout treatment until 30 days after surgery and were evaluated according to Common Terminology Criteria for Adverse Events (version 5.0).

    Measured: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).

Secondary outcomes (2)

  1. Tumor viability assessment

    Densitometric measurement of tumor viability using a modification of the Choi criteria was performed to evaluate the effect. Briefly, using axial source computed tomography images (1.5 mm thickness) a three-dimensional image of the kidney was reconstructed with an imaging workstation (Terra Recon, San Mateo, CA).

    Measured: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).

  2. Progression free survival

    Progression free survival was assessed by imaging (enhanced CT, enhanced MRI or both ) after surgery every 12 weeks until 12 months.

    Measured: Every 12 weeks until 12 months after surgery

Timeline

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

  1. First posted3 Aug 2022
  2. Study start1 Jul 2022
  3. Primary completion31 Dec 2023
  4. Study completion2 Sep 2024

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
Single Group Assignment
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485896
Sponsor's protocol ID
PELUR
Status last verified
Sep 2024
First submitted
25 Jul 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, Grunwald V, Hutson TE, Kopyltsov E, Mendez-Vidal MJ, Kozlov V, Alyasova A, Hong SH, Kapoor A, Alonso Gordoa T, Merchan JR, Winquist E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer A, Procopio G, Takagi T, Melichar B, Rolland F, De Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Apr 8;384(14):1289-1300. doi: 10.1056/NEJMoa2035716. Epub 2021 Feb 13.

    PubMed 33616314

  • Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Chang YH, Hajek J, Symeonides SN, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Gurney H, Chevreau C, Melichar B, Kopyltsov E, Alva A, Burke JM, Doshi G, Topart D, Oudard S, Hammers H, Kitamura H, Bedke J, Perini RF, Zhang P, Imai K, Willemann-Rogerio J, Quinn DI, Powles T; KEYNOTE-564 Investigators. Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. N Engl J Med. 2021 Aug 19;385(8):683-694. doi: 10.1056/NEJMoa2106391.

    PubMed 34407342

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab plus Lenvatinib in people with 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tumor responses (time frame: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).). 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 NCT05485896, which also lists 2 linked publications.

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 19 Sep 2024.

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