Analysis of the efficacy and safety of avelumab maintenance therapy in subgroups of patients with metastatic urothelial carcinoma in real-world practice (RAVE-Bladder Study)
Ya. V. Gridneva,
M. I. Volkova,
Yu. V. Anzhiganova,
V. S. Bragina,
V. A. Vodolazsky,
M. I. Gluzman,
R. A. Zukov,
A. M. Ivanov,
E. R. Israelyan,
E. V. Karabina,
E. I. Kopyltsov,
A. A. Keln,
A. S. Kalpinsky,
A. A. Lebedinets,
A. S. Mochalova,
O. Yu. Novikova,
R. V. Orlova,
E. L. Parsadanova,
V. V. Petkau,
I. A. Pokataev,
A. A. Rumyantsev,
S. Z. Safina,
O. A. Stativko,
A. V. Sultanbaev,
N. A. Tovbik,
A. O. Shkurat,
I. V. Tsimafeyeu https://doi.org/10.18027/2224-5057-2025-066
Abstract
Objective: To evaluate the efficacy and safety of avelumab maintenance therapy in patients with metastatic urothelial carcinoma (UC) in real-world practice.
Methods: This ambispective study included patients with metastatic UC and measurable tumor lesions, without progression during and after first-line platinum-based chemotherapy (CHT), who received avelumab maintenance therapy (800 mg IV every 2 weeks). The primary endpoint of the study was overall survival (OS).
Results: The study included 110 patients, with a predominance of men (81 %). The median age of all patients was 65 (range, 36–84) years. With a median follow-up of 11.9 months, the median OS was not reached; the one-year OS was 78.7 %. The median progression-free survival (PFS) was 9.5 months (95 % CI, 7.8–11.2 months). The objective response rate (ORR) to first-line chemotherapy was 48.2 %. Of the 97 patients with an evaluated objective response, 38 (39.2 %) demonstrated additional objective responses to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were observed in 11.8 % of patients.
Conclusions: The efficacy and safety of avelumab maintenance therapy in real-world practice are comparable to those in the pivotal study.
About the Authors
Ya. V. Gridneva
Oncology Center No. 1 of the City Clinical Hospital named after S. S. Yudin of the Moscow Department of Health; I. M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University); Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Gridneva Yana Vladimirovna
18A Zagorodnoe Shosse, Moscow 117152
Build. 2, 8 Trubetskaya St., Moscow 119991
Build. 1, 2 / 1 Barrikadnaya St., Moscow 125993
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
M. I. Volkova
Oncology Center No. 1 of the City Clinical Hospital named after S. S. Yudin of the Moscow Department of Health; Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Volkova Maria Igorevna
18A Zagorodnoe Shosse, Moscow 117152
Build. 1, 2 / 1 Barrikadnaya St., Moscow 125993
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
Yu. V. Anzhiganova
13A. I. Kryzhanovskiy Krasnoyarsk Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Anzhiganova Yulia Vladimirovna
16 1‑ya Smolenskaya St., Krasnoyarsk 660133
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
V. S. Bragina
Tver Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Bragina Varvara Sergeevna
57 / 37 15 Let Oktyabrya St., Tver 170008
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
V. A. Vodolazsky
Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Vodolazsky Vladislav Anatolyevich
Build 1, 19 Zavertyaeva St., Omsk 644013
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
M. I. Gluzman
City Clinical Oncological Dispensary
Russian Federation
Competing Interests:
Russian Federation
Gluzman Mark Igorevich
56 Veteranov Prospekt, Saint Petersburg 198255
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
R. A. Zukov
Krasnoyarsk State Medical University named after Professor V. F. Voino‑Yasenetsky, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Zukov Ruslan Alexandrovich
1 Partizana Zheleznyaka St., Krasnoyarsk 660022
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. M. Ivanov
Center for Immune and Targeted Therapy
Russian Federation
Competing Interests:
Russian Federation
Ivanov Alexey Mikhailovich
3 Bryanskaya St., Moscow 121059
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
E. R. Israelyan
N. N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Israelyan Edgar Rudikovich
23 Kashirskoe Shosse, Moscow 115478
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
E. V. Karabina
Tula Regional Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Karabina Elena Vladimirovna
60 Kaluzhskoe Shosse, Tula 300039
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
E. I. Kopyltsov
Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Kopyltsov Evgeny Ivanovich
Build 1, 19 Zavertyaeva St., Omsk 644013
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. A. Keln
Tyumen State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Cologne Artem Alexandrovich
54 Odesskaya St., Tyumen 625023
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. S. Kalpinsky
P. A. Hertsen Moscow Oncology Research Institute — branch of the National Medical Research Radiological Center, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Kalpinsky Alexey Sergeevich
3 2nd Botkinskiy proezd, Moscow 125284
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. A. Lebedinets
Leningrad Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
Lebedinets Andrey Alexandrovich
Build. 2, 45 Prospekt Lunacharskogo, Saint Petersburg 194291
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. S. Mochalova
Medsi Group of Companies
Russian Federation
Competing Interests:
Russian Federation
Mochalova Anastasia Sergeevna
Build. 1, 2 Poselok Otradnoe, Krasnogorsk 143442
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
O. Yu. Novikova
Regional Clinical Oncology Center
Russian Federation
Competing Interests:
Russian Federation
Novikova Olga Yurievna
164 Voronezhskoe Shosse, Khabarovsk 680042
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
R. V. Orlova
City Clinical Oncological Dispensary
Russian Federation
Competing Interests:
Russian Federation
Orlova Rashida Vakhidovna
56 Veteranov Prospekt, Saint Petersburg 198255
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
E. L. Parsadanova
Sakhalin Regional Clinical Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
Parsadanova Elvira Levonovna
3 Gor’kogo St., Yuzhno‑Sakhalinsk 693010
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
V. V. Petkau
Ural State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Petkau Vladislav Vladimirovich
3 Repina St., Ekaterinburg 620028
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
I. A. Pokataev
Oncology Center No. 1 of the City Clinical Hospital named after S. S. Yudin of the Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Pokataev Ilya Anatolievich
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. A. Rumyantsev
N. N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
Competing Interests:
Russian Federation
Rumyantsev Alexey Alexandrovich
23 Kashirskoe Shosse, Moscow 115478
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
S. Z. Safina
Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M. Z. Sigal
Russian Federation
Competing Interests:
Russian Federation
Safina Sufiya Zyevna
29 Sibirsky Trakt St., 420029 Kazan
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
O. A. Stativko
Oncology Center No. 1 of the City Clinical Hospital named after S. S. Yudin of the Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Stativko Olesya Alekseevna
18A Zagorodnoe Shosse, Moscow 117152
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. V. Sultanbaev
Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan; Bashkir State Medical University, Ministry of Health of the Russia; Republican Medical and Genetic Center
Russian Federation
Competing Interests:
Russian Federation
Sultanbaev Alexander Valerievich
73 / 1 Prospekt Oktyabrya, 450054 Republic of Bashkortostan, Ufa;
3 Lenina St., 450008 Republic of Bashkortostan, Ufa;
74 Gafuri St., 450076 Republic of Bashkortostan, Ufa
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
N. A. Tovbik
Amur Regional Oncology Dispensary
Russian Federation
Competing Interests:
Russian Federation
110 Oktyabrskaya St., 675005 Blagoveshchensk
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
A. O. Shkurat
Leningrad Regional Clinical Hospital
Russian Federation
Competing Interests:
Russian Federation
Shkurat Alexey Olegovich
Build. 2, 45 Prospekt Lunacharskogo, Saint Petersburg 194291
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
I. V. Tsimafeyeu
Bureau for Cancer Research
Russian Federation
Competing Interests:
Russian Federation
Tsimafeyeu Ilya Valerievich
2 Pereulok Mayakovskogo, 109147 Moscow
Competing Interests:
R. V. Orlova, I. A. Pokataev are members of the editorial board of the journal “Malignant Tumors” since 2019. E. V. Karabina, A. A. Rumyantsev are members of the editorial board of the journal “Malignant Tumors” since 2023. E. R. Israelyan has been a member of the editorial board of the journal “Malignant Tumors” since 2025 but had no role in the decision to publish this article. The article has undergone the journal’s established peer-review process. The authors declared no other conflicts of interest.
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Gridneva Ya.V., Volkova M. ., Anzhiganova Yu. ., Bragina V.S., Vodolazsky V.A., Gluzman M. ., Zukov R.A., Ivanov A.M., Israelyan E.R., Karabina E.V., Kopyltsov E. ., Keln A.A., Kalpinsky A.S., Lebedinets A. ., Mochalova A.S., Novikova O.Yu., Orlova R. ., Parsadanova E.L., Petkau V.V., Pokataev I.A., Rumyantsev A.A., Safina S.Z., Stativko O.A., Sultanbaev A.V., Tovbik N. ., Shkurat A.O., Tsimafeyeu I.V. Analysis of the efficacy and safety of avelumab maintenance therapy in subgroups of patients with metastatic urothelial carcinoma in real-world practice (RAVE-Bladder Study). Malignant tumours. 2026;16(1):21-32. (In Russ.) https://doi.org/10.18027/2224-5057-2025-066
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