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Background Currently cancer patients treated with immune checkpoint modulators (ICMs) have their health related quality of life (HRQOL) measured by general patient reported outcome (PRO) tools such as the EORTC QLQC30 or Functional Assessment of Cancer Therapy-General (FACT-G). No instrument has been developed specifically for patients treated with ICMs, which may lead to their HRQOL being evaluated inaccurately. The objective of this study was to develop a toxicity subscale PRO instrument for ICM treated patients that would contribute to the measurement of HRQOL. Methods Input was collected from a prior systematic review, patients and physicians. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed the development of an initial list of items that described ICM side effects (SEs) and their impacts upon HRQOL. Physician surveys and interviews informed subsequent item generation/reduction. Cognitive debriefing interviews were conducted with a new set of patients after they completed the toxicity subscale. Results Focus groups and individual interviews with 37 ICM-treated patients generated an initial list of 176 items. Following a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for ICM treated patients were surveyed with a list of 49 patient reported toxicity related unique SEs; and 11 physicians participated in follow up interviews. Informed by the data collected from the physicians, a second round of item reduction produced a list of 25 items that covered a wide range of SEs including but not limited to gastrointestinal, cutaneous, musculoskeletal, respiratory, constitutional, neurological and endocrine. This final list was piloted with 11 patients who confirmed that it was comprehensible and complete. Conclusions This 25 item list is the first HRQOL toxicity subscale developed with patient and clinician input for patients treated with ICMs. The subscale will be combined with the FACT-G to form the FACT-ICM and this PRO instrument will undergo further validity testing. Clinical trial identification NCT02651831. Legal entity responsible for the study Princess Margaret Cancer Centre. Funding University of Toronto, Strategic Innovation Grant. Disclosure A.R. Hansen: Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): GSK; Advisory / Consultancy, Research grant / Funding (institution): Roche-Genentech; Advisory / Consultancy, Research grant / Funding (institution): MedImmune; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Boston Biomedical; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb. P. Bedard: Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Genentech/Roche; Research grant / Funding (institution): Servier; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): SignalChem; Research grant / Funding (institution): PTC Therapeutics; Research grant / Funding (institution): Nektar; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Seattle Genetics; Research grant / Funding (institution): Mersana; Research grant / Funding (institution): Immunomedics; Research grant / Funding (institution): Lilly. All other authors have declared no conflicts of interest.