Trial reportJournal for immunotherapy of cancer2022
Bempegaldesleukin plus nivolumab in first-line renal cell carcinoma: results from the PIVOT-02 study.
Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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The trial behind it
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Who cites it
17 citing papers in PubMed, 26 citations in OpenAlex.
- Interleukin-2 transcriptomic expression correlates with prolonged survival and with GNAS alterations in patients with advanced cancers.ESMO open · 2026Article
- Immunosuppressive tumor microenvironment shape pancreatic cancer unresponsive to current immunotherapies.World journal of clinical oncology · 2026Review
- "Cytokine-Mediated tumor sensitization: mechanistic frameworks and therapeutic opportunities in cancer Immunotherapy".Clinical and experimental medicine · 2026Review
- Current landscape and future prospects of interleukin-2 receptor (IL-2R) agonists in cancer immunotherapy.Oncoimmunology · 2025Review
- Potentiating intratumoral therapy with immune checkpoint inhibitors: shifting the paradigm of multimodality therapeutics.Immuno-oncology technology · 2025Review
- Present and future of cancer nano-immunotherapy: opportunities, obstacles and challenges.Molecular cancer · 2025Review
- Review
- CLN-617 Retains IL2 and IL12 in Injected Tumors to Drive Robust and Systemic Immune-Mediated Antitumor Activity.Cancer immunology research · 2024Article
- Exploring the Complexity and Promise of Tumor Immunotherapy in Drug Development.International journal of molecular sciences · 2024Review
- B cells and the coordination of immune checkpoint inhibitor response in patients with solid tumors.Journal for immunotherapy of cancer · 2024Review
- Rationale for immune checkpoint inhibitors plus targeted therapy for advanced renal cell carcinoma.Heliyon · 2024Review
- Update on combined immunotherapy for the treatment of advanced renal cell carcinoma.Human vaccines & immunotherapeutics · 2023Review
- Immune approaches beyond traditional immune checkpoint inhibitors for advanced renal cell carcinoma.Human vaccines & immunotherapeutics · 2023Review
- Revisiting mechanisms of resistance to immunotherapies in metastatic clear-cell renal-cell carcinoma.Cancer drug resistance (Alhambra, Calif.) · 2023Review
- Treatment strategies for clear cell renal cell carcinoma: Past, present and future.Frontiers in oncology · 2023Review
- Clinical potential of PD-1/PD-L1 blockade therapy for renal cell carcinoma (RCC): a rapidly evolving strategy.Cancer cell international · 2022Review
- Determining Front-Line Therapeutic Strategy for Metastatic Clear Cell Renal Cell Carcinoma.Cancers · 2022Review
Corrections and comments
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Authors and funding
18 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmune checkpoint inhibitor-based combinations have expanded the treatment options for patients with renal cell carcinoma (RCC); however, tolerability remains challenging. The aim of this study was to evaluate the safety and efficacy of the immunostimulatory interleukin-2 cytokine prodrug bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) as first-line therapy in patients with advanced clear-cell RCC.
methodsThis was an open-label multicohort, multicenter, single-arm phase 1/2 study; here, we report results from the phase 1/2 first-line RCC cohort (N=49). Patients received BEMPEG 0.006 mg/kg plus NIVO 360 mg intravenously every 3 weeks. The primary objectives were safety and objective response rate (ORR; patients with measurable disease at baseline and at least one postbaseline tumor response assessment). Secondary objectives included overall survival (OS) and progression-free survival (PFS). Exploratory biomarker analyses: association between baseline biomarkers and ORR.
resultsAt a median follow-up of 32.7 months, the ORR was 34.7% (17/49 patients); 3/49 patients (6.1%) had a complete response. Of the 17 patients with response, 14 remained in response for >6 months, and 6 remained in response for >24 months. Median PFS was 7.7 months (95% CI 3.8 to 13.9), and median OS was not reached (95% CI 37.3 to not reached). Ninety-eight per cent (48/49) of patients experienced ≥1 treatment-related adverse event (TRAE) and 38.8% (19/49) had grade 3/4 TRAEs, most commonly syncope (8.2%; 4/49) and increased lipase (6.1%; 3/49). No association between exploratory biomarkers and ORR was observed. Limitations include the small sample size and single-arm design.
conclusionsBEMPEG plus NIVO showed preliminary antitumor activity as first-line therapy in patients with advanced clear-cell RCC and was well tolerated. These findings warrant further investigation.
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