Clinical trial · Observational
Retrospective Study of COVID-19 Vaccines in Patients Undergoing Immunotherapy for Cancer.
Pharmaco-epidemiological Study of COVID 19 Vaccines in Patients Undergoing Immunotherapy for Cancer. A Retrospective Open Cohort Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): end of the COVID outbreak
Summary
Brief summary (as posted)
The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J \& J COVID-19 Vaccine.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients treated for cancer, vaccinated or eligible for anti-COVID vaccination.
- description
- Patients undergoing treatment with anti-PD immunotherapy, anti-PDL1 or anti-CTLA4 immunotherapy for any tumour (solid, liquid) treated in the medical oncology departments of the Occitanie area. who have been vaccinated or who are eligible for inoculation with one of the available anti-COVID19 vaccines.
Primary outcomes (9)
- measure
- Tolerance of immunotherapy following anti-COVID-19 vaccination
- timeFrame
- 24 hours after the vaccination
- description
- All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.
- measure
- Tolerance of immunotherapy following anti-COVID-19 vaccination
- timeFrame
- 48 hours after the vaccination
- description
- All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient having been vaccinated or eligible for inoculation with one of the available anti-COVID19 vaccines (except live attenuated virus) while they were or are undergoing immunotherapy with anti-PD1, anti-PDL1 or anti-CTLA4 immunotherapy whatever the tumor (solid, liquid) managed within the medical oncology services of the Occitanie region. * Patients affiliated to or beneficiaries of a health insurance scheme. * Patients who have received written and oral information about the study and who have no objection to participation. * Adult patients (≥ 18 years). Exclusion Criteria: * Patients who have been vaccinated with a live attenuated vaccine. * Patients with a contraindication to inclusion (including hypersensitivity to the active substance or to one of the excipients, COVID+ PCR test in the last 3 months). * Minor patients, pregnant women, parturients, nursing mothers, persons in nursing mothers, persons in emergency situations, persons unable to persons unable to express their consent and persons under persons under court protection, subguardianship or subguardianship may not be included in this research. * Patients in an exclusion period determined by another study. * Patients for whom it is impossible to give clear information. * Patients who have expressed an objection to participating in the study.
References
Publications (6)
- BACKGROUNDBaden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30. PMID 33378609
- BACKGROUNDKnoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8. No abstract available. PMID 33306990
- BACKGROUNDVoysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. PMID 33306989
- BACKGROUNDSadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.