Source Articles
Nivolumab
Showing 18 study arms
with grade ≥3 adverse event data (treatment-related and RT-related).
Click a column header to sort.
Note on patient counts: some articles reported only percentages rather
than absolute numbers. Where this occurred, the number of patients — including those with
grade ≥3 adverse events — was derived by applying the reported percentage to the total arm
size, which may produce a non-integer value. These figures have been rounded to the nearest
integer for display.
| 1st Author | Year | Study Type | Title | DOI | clinical trial number | number of patients | median/mean age | median follow-up [months] | tumor type | treatment setting | drug group | drug name | if other, please specify | number of SBRT courses | intracranial / extracranial | treated site | If other treated site, please specify | median/mean total RT dose [Gy] | minimum total RT dose [Gy] | maximum total RT dose [Gy] | median/mean number of fractions | minimum number of fractions | maximum number of fractions | median/mean dose per fraction [Gy] | minimum dose per fraction [Gy] | maximum dose per fraction [Gy] | toxicity type | patients with acute G>=3 toxicity | patients with late G>=3 toxicity | patients with G>=3 toxicity, timing unspecified | G>=3 AEs | patients with G>=3 AEs | details on G>=3 toxicity | details on G>=3 toxicity in RT field |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Schvartsman et al. | 2026 | Prospective | Pathologic Responses to Stereotactic Ablative Radiotherapy in Combination With Nivolumab for Early Stage NSCLC: A Phase 2 Study | 10.1016/j.jtocrr.2025.100940 | NCT04271384 | 25 | 66 | 12.1 | Lung cancer | primary | Anti-PD-(L)1 mAb | Nivolumab | — | 25 | extra-cranial | lung | — | 50 | 50 | 54 | 5 | 3 | 5 | 10 | 10 | 18 | Treatment-rel. | — | — | 2 | any G3: 2 AEs | any G3: 2 pts |
any G3: diarrhea
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| Chiang et al. | 2024 | Retrospective | Survival Outcome Analysis of Stereotactic Body Radiotherapy and Immunotherapy (SBRT-IO) versus SBRT-Alone in Unresectable Hepatocellular Carcinoma | 10.1159/000533425 | — | 30 | 73 | 19 | HCC | primary | Anti-PD-(L)1 mAb | Nivolumab | — | 100 | extra-cranial | liver | — | 30 | 25 | 45 | 5 | 5 | 5 | — | — | — | Treatment-rel. | — | — | 10 | G3 or G4: 7 AE | Missing |
any G3 or G4: bilirubin elevated, AST/ALT elevated, fatigue, pruritis
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| Markussen et al. | 2024 | Prospective | Nivolumab With or Without Ipilimumab Combined with Stereotactic Body Radiotherapy in patients with Metastatic Biliary Tract Cancer: A Randomized Phase 2 Study | 10.1158/1078-0432.Ccr-24-0286 | NCT05184400 | 19 | 66 | 10.6 | other | metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | Missing | extra-cranial | lung, liver, bone, LN unspecified, other | peritoneum, other sites not specified | 15 | 15 | 15 | 1 | 1 | 1 | 15 | 15 | 15 | Treatment-rel. | — | — | 3 | unknown | any G>=3: 3 pts |
TRAEs not described separately
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unknown
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| Vošmik et al. | 2024 | Prospective | Stereotactic Radiotherapy Plus Nivolumab in Patients with Locally Advanced Pancreatic Cancer: Results from Phase 1/2 Clinical CA209-9KH Trial. | 10.1007/s40487-024-00309-z | NCT04098432 | 15 | 58 | Missing | pancreas | primary | Anti-PD-(L)1 mAb | Nivolumab | — | 15 | extra-cranial | other | Pancreas | 32 | 32 | 32 | 4 | 4 | 4 | 8 | 8 | 8 | Treatment-rel. | — | — | 2 | any G3: 2 AEs | any G3: 2 pts |
any G3: elevated liver enzyme levels, arthralgia
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| Chang et al. | 2023 | Prospective | Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial | 10.1016/s0140-6736(23)01384-3 | — | 66 | 72 | 33 | Lung cancer | primary | Anti-PD-(L)1 mAb | Nivolumab | — | Missing | extra-cranial | lung | — | Missing | 50 | 70 | Missing | 4 | 10 | Missing | 12.5 | 7 | Treatment-rel. | — | — | 10 | Missing | any G3: 10 pt |
Missing
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| Franzese et al. | 2023 | Retrospective | The impact of stereotactic ablative radiotherapy on oligoprogressive metastases from renal cell carcinoma | 10.1007/s00432-022-04352-z | — | 11 | 63.4 | 19 | Kidney cancer | oligometastatic | Anti-PD-(L)1 mAb | Nivolumab | — | 74 | both | brain, lung, liver, adrenal gland, bone, muscle, LN unspecified, other | pancreas | 40 | 16 | 60 | Missing | 1 | 6 | Missing | Missing | Missing | Treatment-rel. | 0 | 0 | — | 0 | 0 |
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| Juloori et al. | 2023 | Prospective | Phase 1 Randomized Trial of Stereotactic Body Radiation Therapy Followed by Nivolumab plus Ipilimumab or Nivolumab Alone in Advanced/Unresectable Hepatocellular Carcinoma | 10.1016/j.ijrobp.2022.09.052 | NCT03203304 | 6 | 69 | 42.7 | HCC | primary | Anti-PD-(L)1 mAb | Nivolumab | — | 6 | extra-cranial | liver | — | 40 | 40 | 40 | 5 | 5 | 5 | 8 | 8 | 8 | Treatment-rel. | — | — | 3 | any G3: 4 AE | any G3: 3 pt |
any G3: AST/ALT increased, hyponatremia, fatigue, generalized muscle weakness
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| Chen et al. | 2022 | Prospective | Randomized Phase II Study of Nivolumab With or Without Ipilimumab Combined With Stereotactic Body Radiotherapy for Refractory Metastatic Pancreatic Cancer (CheckPAC) | 10.1200/jco.21.02511 | — | 41 | 63 | 4.1 | pancreas | metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | 41 | extra-cranial | lung, liver, abdominal LN, other | pancreas | 15 | 15 | 15 | 1 | 1 | 1 | 15 | 15 | 15 | Treatment-rel. | — | — | 10 | Missing | G3 or G4: 10 pt |
any G3 or G4: fatigue, diarrhea, arthralgia, myalgia, increased ALT, increased AST, increased ALP, Guillain-Barre syndrome
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| Masini et al. | 2022 | Prospective | Nivolumab in Combination with Stereotactic Body Radiotherapy in Pretreated Patients with Metastatic Renal Cell Carcinoma. Results of the Phase II NIVES Study | 10.1016/j.eururo.2021.09.016 | NCT0346971 | 69 | 66 | 26 | Kidney cancer | metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | 66 | extra-cranial | lung, liver, adrenal gland, LN unspecified, other | bone, kidney | 30 | 30 | 30 | 3 | 3 | 3 | 10 | 10 | 10 | Treatment-rel. | — | — | 18 | any G3-4: 16 AEs (Table 3) | any G3-4: 18 pts (Text) |
any G3-4: rash, diarrhea, colitis, hyperamylsemia/hyperlipasemia, neurologic disorder, hematologic, fatigue
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| Sari et al. | 2022 | Retrospective | Results of concurrent radiotherapy and immunotherapy in recurrent and metastatic head and neck cancer: A single-center experience | 10.1016/j.oraloncology.2021.105658 | — | 15 | 55 | — | Head and neck cancer | — | Anti-PD-(L)1 mAb | Nivolumab | — | 25 | extra-cranial | cutaneous, cervical lymph nodes, axillary LN, other | Nasopharynx | 24 | — | — | 3 | — | — | 8 | — | — | RT-related | 0 | — | — | acute G3-4: none, late G3-4: unknown, late G5: 1 AE | late G3-4: unknown, late G5: 1 pt |
late G5: skull base osteomyelitis
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unknown
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| Ahmed et al. | 2021 | Prospective | Nivolumab and Stereotactic Radiosurgery for Patients With Breast Cancer Brain Metastases: A Nonrandomized, Open-Label Phase 1b Study | 10.1016/j.adro.2021.100798 | NCT03807765 | 12 | 58 | 9.6 | Breast cancer | metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | 17 | intra-cranial | brain | — | Missing | 12 | 25 | Missing | 1 | 5 | Missing | 5 | 24 | Treatment-rel. | — | — | 1 | any G3: 1 AE | any G3: 1 pt |
any G3: cerebral edema
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any G3: cerebral edema
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| Franzese et al. | 2021 | Retrospective | The role of stereotactic body radiation therapy and its integration with systemic therapies in metastatic kidney cancer: a multicenter study on behalf of the AIRO (Italian Association of Radiotherapy and Clinical Oncology) genitourinary study group | 10.1007/s10585-021-10131-w | — | 14 | Missing | 18.6 | Kidney cancer | oligometastatic | Anti-PD-(L)1 mAb | Nivolumab | — | Missing | extra-cranial | lung, liver, adrenal gland, bone, muscle, LN unspecified, other | Renal bed, Pancreas | 36 | 10 | 75 | 5 | 1 | 10 | Missing | Missing | Missing | Treatment-rel. | 0 | 0 | 0 | 0 | 0 |
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| Ye et al. | 2021 | Prospective | Nivolumab and Hypofractionated Radiotherapy in Patients With Advanced Lung Cancer: ABSCOPAL-1 Clinical Trial | 10.3389/fonc.2021.657024 | ChiCTR-1900027768 | 14 | 54 | 11 | Lung cancer | metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | Missing | extra-cranial | LN unspecified, lung | — | Missing | 40 | 50 | 5 | 5 | 5 | Missing | 8 | 10 | Treatment-rel. | — | — | 0 | — | — |
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| Yuce Sari et al. | 2021 | Retrospective | Does Combined Fractionated Stereotactic Radiotherapy and Immunotherapy Change the Outcome of Recurrent High-Grade Gliomas? | 10.7759/cureus.15852 | — | 8 | 52 | 12.6 | brain | primary | Anti-PD-(L)1 mAb | Nivolumab | — | 8 | intra-cranial | brain | — | 24 | 24 | 24 | 3 | 3 | 3 | 8 | 8 | 8 | Treatment-rel. | — | — | 2 | any G3: 4 AEs | any G3: 2 pts |
any G3: pneumonitis, osteoporosis, radiation necrosis
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unknown
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| Dengina et al. | 2019 | Prospective | Stereotactic body radiation therapy in combination with systemic therapy for metastatic renal cell carcinoma: a prospective multicentre study | 10.1136/esmoopen-2019-000535 | NCT02864615 | 5 | 54.5 | 8 | Kidney cancer | any | Anti-PD-(L)1 mAb | Nivolumab | — | 5 | extra-cranial | lung, liver, bone, LN unspecified, other | kidney | Missing | Missing | Missing | Missing | Missing | Missing | Missing | Missing | Missing | Treatment-rel. | — | — | 0 | 0 | 0 |
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| Minniti et al. | 2019 | Retrospective | Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity | 10.1186/s40425-019-0588-y | — | 35 | 56 | 15 | Melanoma | oligometastatic, metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | Missing | intra-cranial | brain | — | Missing | 18 | 27 | Missing | 1 | 3 | Missing | 9 | 22 | Treatment-rel. | — | — | 6 | any G3: 14 AEs | any G3: 6 pts |
any G3: Diarrhoea, Nausea/Vomiting, Increased AST and/or ALT levels, Fatigue, Rash/Pruritus, Muscle weakness, Headache, Hemorrhage, Seizure, Brain necrosis
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unknown
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| Miyamoto et al. | 2019 | Prospective | Nivolumab and stereotactic radiation therapy for the treatment of patients with Stage IV non-small-cell lung cancer | 10.1093/jjco/hyy171 | unknown | 6 | Missing | Missing | Lung cancer | metastatic | Anti-PD-(L)1 mAb | Nivolumab | — | 6 | extra-cranial | lung | — | Missing | 25.5 | 48 | Missing | 3 | 4 | Missing | 8.5 | 12 | Treatment-rel. | — | — | 1 | any G3: 1 AE | any G3: 1 pt |
any G3: Pneumonitis
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unknown
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| Sundahl et al. | 2019 | Prospective | Phase 2 Trial of Nivolumab Combined With Stereotactic Body Radiation Therapy in Patients With Metastatic or Locally Advanced Inoperable Melanoma | 10.1016/j.ijrobp.2019.03.041 | NCT02821182 | 20 | 60.5 | 13.1 | Melanoma | any | Anti-PD-(L)1 mAb | Nivolumab | — | 20 | extra-cranial | Missing | — | 24 | 24 | 24 | 3 | 3 | 3 | 8 | 8 | 8 | Treatment-rel. | — | — | 3 | any G3: 3 AEs | any G3: 3 pts |
any G3: bullous pemphigoid, gastroenteritis, lymphopenia
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any G3: bullous pemphigoid
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