Bavencio (avelumab) / EMD Serono - LARVOL DELTA

A phase II study of avelumab in locally advanced or metastatic penile cancer patients unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy (ALPACA) (ESMO 2025) - P2 | "Conclusions Single-agent Avelumab was well-tolerated and demonstrated modest activity with a 21% clinical benefit rate in previously treated advanced PSCC, consistent with prior studies. These findings support further investigation of ICIs and biomarker-driven strategies in this population."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Genito-urinary Cancer • Oncology • Penile Cancer • Squamous Cell Carcinoma

DISCUS: A phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer (ESMO 2025) - P2 | "Methods Pts with previously untreated aUC were randomized 1:1 to receive 3 (3C arm) or 6 (6C arm) cycles of gemcitabine/cisplatin or gemcitabine/carboplatin, followed by maintenance avelumab. Grade 3–4 TRAEs occurred in 11.9% (3C) vs 15.7% (6C). Conclusions Three cycles of platinum-based chemotherapy followed by avelumab provides better QoL compared with six cycles, and similar OS without compromising efficacy."

Clinical • Late-breaking abstract • Metastases • P2 data • Genito-urinary Cancer • Oncology • Urothelial Cancer

Soluble MAdCAM-1 predicts outcomes in patients with metastatic renal cell carcinoma: Results from three independent clinical trials (ESMO 2025) - P2, P3 | "Methods sMAdCAM-1 was measured using the Human Luminex Discovery Assay in plasma from 1,051 patients across the phase 3 JAVELIN Renal 101 trial (1 st line avelumab + axitinib vs. sunitinib) as training cohort and the phase 2 SURF (1 st line sunitinib) and NIVOREN (nivolumab post-TKI) trials as validation cohorts. Conclusions Higher sMAdCAM-1 levels at baseline or their increase during the first cycles of therapy were associated with improved outcomes in patients with mRCC. Our study supports a paradigm shift in the management of mRCC, paving the way to biomarker-guided clinical trials investigating microbiota-targeted interventions aimed at enhancing the efficacy of standard ICI-based therapies."

Biomarker • Clinical • IO biomarker • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Three versus six cycles of platinum-based chemotherapy followed by avelumab maintenance as first-line treatment for advanced urothelial cancer: the phase II DISCUS trial. (PubMed, Ann Oncol) - P2 | "3 cycles of chemotherapy followed by maintenance avelumab is associated with better QoL than 6 cycles. Randomized trials with patients focused outcomes exploring shorter duration of therapy are feasible. (NCT06892860)."

Journal • P2 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Leveraging artificial intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: Translational analyses of AtezoTRIBE and AVETRIC trials (ESMO 2025) - P2 | "Methods Lunit SCOPE IO quantified the density of lymphocytes (LC), fibroblasts (FB), macrophages (MP), tumor (TC), endothelial (EC) and mitotic (MTC) cells in cancer area (CA) and stroma (CS) on pre-treatment H&E WSIs from pts with pMMR mCRC enrolled in AtezoTRIBE (FOLFOXIRI/bevacizumab +/- atezolizumab [atezo]) and AVETRIC (FOLFOXIRI/cetuximab/avelumab) trials...In the AVETRIC cohort, WSIs from 48 pts were analyzed; 36 (75%) cases were classified as biomarker- high , with better PFS ( P = .043) and OS ( P = .053) compared to biomarker- low ones. Conclusions Our AI-derived tumour microenvironment biomarker may help to predict benefit from ICI-based treatments in pMMR mCRC, supporting further investigations of AI-powered approaches."

Checkpoint inhibition • Clinical • IO biomarker • Colorectal Cancer • Oncology

Autoimmunity in the era of immune checkpoint inhibitors: the evolving epidemiology of autoimmune diseases and the possible impact of COVID-19. (PubMed, Autoimmun Rev) - "We then focus on the autoimmune nature of these side effects, with particular attention to the epidemiology of autoimmune diseases, including their female preponderance in certain age groups. In the final sections, we discuss how irAEs may be altering the epidemiology of autoimmune disease and address the possible effect of COVID-19 as a potential trigger."

Checkpoint inhibition • Journal • Review • Gastrointestinal Disorder • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology

Emerging Therapeutic Synergies: Combining PD-1 Inhibitors With Poly-ADP-Ribose Polymerase (PARP) Inhibitors in the Treatment of Gynecologic Cancers. (PubMed, Cureus) - "In recurrent ovarian cancer, niraparib+pembrolizumab showed modest activity with durable responses in homologous recombination-deficient (HRD) tumors; olaparib+durvalumab demonstrated high activity in gBRCA platinum-sensitive relapse, and adding bevacizumab broadened benefit in non-BRCA cohorts. In the newly diagnosed disease, rucaparib+nivolumab maintenance failed to improve PFS versus rucaparib alone. Endometrial trials (olaparib+durvalumab; talazoparib+avelumab in mismatch repair-proficient disease) showed limited activity overall, with signals restricted to biomarker-selected subgroups...PARP+PD-1/PD-L1 combinations are most compelling in ovarian cancer, particularly in BRCA/HRD tumors and, in selected settings, with the addition of bevacizumab, while frontline maintenance benefit remains unproven and endometrial activity is modest. Biomarker-guided selection, rational triplets with non-cytotoxic partners, and optimized sequencing warrant further evaluation."

IO biomarker • Journal • Review • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Gynecology • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD • STING

Phase 2 trial of perioperative chemo-immunotherapy for gastro-esophageal adenocarcinoma: The role of M2 macrophage landscape in predicting response. (PubMed, Cell Rep Med) - P2 | "We present the clinical results of a phase 2 trial combining neoadjuvant docetaxel, cisplatin, 5 Flourouracil, and the PD-L1 inhibitor avelumab in locally advanced gastro-esophageal adenocarcinoma (GEA). The specific character of the inflammatory environment in non-responders may, in the future, help personalize treatment. This study was registered at ClinicalTrials.gov (NCT03288350)."

Journal • P2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Early ctDNA and Survival in Metastatic Colorectal Cancer Treated With Immune Checkpoint Inhibitors: A Secondary Analysis of the SAMCO-PRODIGE 54 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "This prespecified secondary analysis of the SAMCO-PRODIGE 54 randomized clinical trial evaluated ctDNA in patients with dMMR/MSI-H mCRC treated with avelumab or standard chemotherapy, with or without a targeted agent in the second-line setting, to assess its prognostic role...The findings of this secondary analysis of an RCT found that change in ctDNA at 1-month posttreatment can predict long-term outcomes in patients with dMMR/MSI-H mCRC treated with ICIs. ClinicalTrials.gov Identifier: NCT03186326."

Checkpoint inhibition • Circulating tumor DNA • Clinical • IO biomarker • Journal • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • WIF1

Surgical outcomes post-total mesorectal excision in patients with locally advanced rectal cancer undergoing total neoadjuvant treatment with short-course radiotherapy followed by chemo-immunotherapy: Data from the phase II Averectal trial (ESMO-GI 2025) - P2 | "The Averectal trial demonstrated that integrating avelumab with neoadjuvant SCRT and FOLFOX, followed by TME, resulted in acceptable surgical toxicity. These findings highlight the need for careful perioperative management and patient selection to reduce surgical risks."

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

JAVELIN Bladder Medley phase 2 trial of avelumab + sacituzumab govitecan (Ave + SG) vs avelumab monotherapy (Ave mono) as first-line maintenance (1LM) treatment for advanced urothelial carcinoma (aUC): subgroup analyses based on metastatic sites (DKK 2026) - No abstract available

Clinical • Metastases • Monotherapy • P2 data • Oncology • Solid Tumor • Urothelial Cancer

Checkpoint Inhibition in Gestational Trophoblastic Neoplasia: A Narrative Review on the Reawakening of Antitumor Immunity. (PubMed, Adv Ther) - "Immunotherapy has expanded therapeutic GTN, transforming refractory disease as a result of its immune responsiveness. Checkpoint inhibition not only achieves high remission rates but also offers fertility preservation and long-term survivorship. The future challenge lies in optimizing combination strategies, refining biomarkers, and ensuring equitable global access to these emerging treatments."

Checkpoint inhibition • IO biomarker • Journal • Review • Gestational Trophoblastic Neoplasia • Oncology • KDR

NF1/2 mutations predict favorable benefit from immune checkpoint inhibitor-based therapies over VEGFR/mTOR inhibitors in clear cell renal cell carcinoma. (PubMed, Clin Exp Med) - "This tendency was not changed by everolimus (HR = 2.66), but was abrogated slightly by sunitinib (HR = 1.59) and considerably by ICI-based therapies, including nivolumab monotherapy (HR = 1.12), atezolizumab plus bevacizumab (HR = 1.10), and avelumab plus axitinib (HR = 0.69). Overall, our findings suggest that NF1/2 mutations can serve as predictive biomarkers for favorable benefits from ICI-based treatments over VEGFR/mTOR inhibitors in advanced ccRCCs."

Checkpoint inhibition • IO biomarker • Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Inflammatory Arthritis • Oncology • Solid Tumor • NF1

SWOG S1931 (PROBE): Phase III randomized trial of immune checkpoint inhibitor (ICI) combination regimen with or without cytoreductive nephrectomy (CN) in advanced renal cancer. (ASCO-GU 2022) - P3 | "CARMENA trial demonstrated no change in overall survival with addition of nephrectomy to sunitinib therapy... Eligible patients with primary tumor and metastases are treated with one of the FDA approved ICI based combinations: ipililumab and nivolumab, axitinib and pembrolizumab, or axitinib and avelumab. Cabozantinib + nivolumab and lenvatinib + pembrolizumab combinations are being added into the next amendment...The study hypothesis is that CN will result in improvement in OS outcomes in advanced synchronous RCC post-initial systemic immune checkpoint based combination therapy. With a sample size of 302 eligible, randomized participants (151 per arm) and a one-sided alpha = 0.025, the study has 85% power to detect a 47% improvement in median survival (HR = 0.68; 1/0.68 = 1.47)"

Checkpoint inhibition • Clinical • P3 data • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Trial of INI-4001 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Inimmune Corporation | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2026 ➔ Mar 2027 | Trial primary completion date: Aug 2024 ➔ Oct 2026

Enrollment open • Trial completion date • Trial primary completion date • Solid Tumor

A single-arm, open-label, single-center, exploratory phase II clinical study of etoposide capsules combined with bevacizumab and avelumab in the treatment of platinum-resistant or platinum-refractory ovarian cancer (ChiCTR) - P2 | N=33 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New P2 trial • Platinum resistant • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • MUC16

Time-Dependent Comparative Effectiveness of First-Line Treatment for Metastatic Clear Cell Renal Cell Carcinoma: A Restricted Mean Survival Time-Based Network Meta-analysis. (PubMed, Target Oncol) - "Given the frequent proportional hazards violations, hazard ratio-only syntheses are insufficient for modern immune checkpoint inhibitor-based regimens. In the restricted mean survival time-based network meta-analysis, Pembrolizumab + Lenvatinib delivered rapid disease control, and Ipilimumab + Nivolumab showed the greatest late survival advantage in IMDC intermediate/poor-risk."

HEOR • Journal • Retrospective data • Review • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Treatment Sequencing in Advanced Urothelial Cancer. (PubMed, Drugs) - "Accordingly, gemcitabine-cisplatin with nivolumab and platinum-based chemotherapy followed by maintenance avelumab remain validated evidence-based alternatives, particularly for cisplatin-eligible patients or in regions where enfortumab vedotin plus pembrolizumab is not readily accessible...Enfortumab vedotin monotherapy retains activity post-platinum and immune checkpoint inhibition, erdafitinib provides a targeted benefit in fibroblast growth factor receptor 3-altered tumors, and trastuzumab deruxtecan has emerged as a later-line option for HER2-positive disease. In parallel, circulating tumor DNA is an emerging biomarker with potential to individualize sequencing strategies, although its clinical application remains investigational. This review synthesizes current evidence and highlights practical considerations, emphasizing the need to balance therapeutic innovation with cost effectiveness, equitable access, and global applicability, while identifying critical..."

IO biomarker • Journal • Review • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR3 • HER-2

Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study. (PubMed, Lancet Oncol) - P2 | "Despite a higher incidence of adverse events, combining atezolizumab with mDCF is feasible, with similar dose intensity in both groups, although the primary efficacy endpoint was not met. The predictive value of a PD-L1 combined positive score of 5 or greater now needs to be confirmed in future studies."

Journal • Metastases • P2 data • Acute Kidney Injury • Anal Carcinoma • Fatigue • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Nephrology • Neutropenia • Oncology • Renal Disease • Sarcoidosis • Solid Tumor • Squamous Cell Carcinoma • PD-1 • PD-L1

Checkpoint Inhibitors and Beyond: A Systematic Review of Immunotherapy in Cutaneous Malignancies. (PubMed, Cureus) - "Melanoma: PD-1 therapies showed durable benefits; ipilimumab retreatment yielded 42% two-year survival. MCC: Avelumab achieved a median OS of 12.9 months. cSCC: Nivolumab PFS 8.2 months; cemiplimab 12-month PFS >53%...Overall, immunotherapy offers substantial, often long-lasting benefits, though careful patient selection and monitoring are essential to balance efficacy and toxicity. Combination immunotherapies and targeted regimens are more effective for advanced melanoma, although they have increased toxicity."

Checkpoint inhibition • IO biomarker • Journal • Review • Basal Cell Carcinoma • Genetic Disorders • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • IL12A

A provocative analysis of first-line strategies in advanced urothelial carcinoma: Reconstructed individual patient data comparisons of EV–pembrolizumab, avelumab maintenance, and nivolumab–cisplatin–gemcitabine from their pivotal phase 3 trials. (ASCO-GU 2026) - "The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Distinct pathways of disease progression with dual checkpoint blockade versus immunotargeted therapy in metastatic renal cell carcinoma. (PubMed, Urol Oncol) - "Nivo-Ipi was associated with more frequent development of new metastatic lesions, particularly in the lungs, bones, and lymph nodes, while axitinib-based combinations more often resulted in regrowth of existing disease with higher rates of adrenal involvement."

Checkpoint inhibition • Journal • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Current Landscape of Sequential Treatment Strategy in Metastatic Urothelial Carcinoma (PubMed, Gan To Kagaku Ryoho) - "In 2024, enfortumab vedotin plus pembrolizumab(EV+P)and nivolumab plus gemcitabine/cisplatin(Nivo+GC)were approved as first-line therapies for metastatic urothelial carcinoma(mUC), marking a major shift in treatment strategy.EV+P, in particular, demonstrated remarkable efficacy and has been assigned the highest level of recommendation in both the 2025 European Association of Urology(EAU)and National Comprehensive Cancer Network(NCCN)guidelines.By contrast, avelumab maintenance therapy following platinum-based chemotherapy-established since its approval in 2021-has long been practiced as a standard approach in Japan.Its major strength lies in the robust real-world evidence accumulated domestically, confirming both efficacy and safety across various patient populations.In the 2025 update of the Japanese Urological Association(JUA)bladder cancer guidelines lists EV+P, Nivo+GC, and avelumab maintenance therapy are all listed as Grade 1, Level A recommendations.However, there..."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology • Urothelial Cancer

CaboPoint: Interim results from a phase 2 study of cabozantinib after checkpoint inhibitor (CPI) therapy in patients with advanced renal cell carcinoma (RCC). (ASCO-GU 2023) - P2 | "Patients received cabozantinib in two independent cohorts (cohort A [post nivolumab + ipilimumab] and cohort B [post CPI + vascular endothelial growth factor targeted therapy])...The most common prior treatment in cohort B was pembrolizumab + axitinib (71.4%), followed by avelumab + axitinib (28.6%)... In this interim analysis, cabozantinib demonstrated preliminary efficacy in patients with advanced RCC after progression on CPI-based combination therapy, irrespective of 1L regimen. The CaboPoint trial is ongoing, with the final analysis anticipated in September 2023. Clinical trial information: NCT03945773."

Checkpoint inhibition • Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 ➔ Aug 2026

Checkpoint inhibition • IO biomarker • Trial completion date • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer