A Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery (PROMO)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||PROMO: A Phase II Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery|
- Clinical benefit rate [ Time Frame: At 18 weeks ]The percentage of patients with unresectable osteosarcoma who have achieved clinical response; complete response (CR), partial response (PR), or stable disease (SD) at 18 weeks as assessed using RECIST v1.1.
- Overall response rate (ORR) [ Time Frame: Assessments every 6-9 weeks up to 2 years ]The percentage of patients with unresectable osteosarcoma who have achieved objective response during treatment; complete response (CR), partial response (PR), as assessed using RECIST v1.1.
- Progression-free survival (PFS) [ Time Frame: Up to 4 years ]
- Response rate by immune-related Response Criteria (ir-RC) [ Time Frame: Assessments every 6-9 weeks up to 2 years ]
- Overall survival (OS) [ Time Frame: Through study completion, up to 4 years after enrollment of last patient ]
- Number and type of Adverse Events related to pembrolizumab treatment in osteosarcoma patients as assessed by CTCAE v4.0 [ Time Frame: Assessments every 6-9 weeks up to 2 years ]To evaluate the safety and tolerability of pembrolizumab in patients with osteosarcoma.
- Health-related quality of life changes using EORTC QLQ-C30 [ Time Frame: Assessments every 6-9 weeks up to 4 years ]To evaluate health-related quality of life changes from baseline in patients with osteosarcoma, receiving pembrolizumab, using EORTC QLQ-C30.
|Anticipated Study Start Date:||May 30, 2017|
|Estimated Study Completion Date:||December 2023|
|Estimated Primary Completion Date:||November 2019 (Final data collection date for primary outcome measure)|
Pembrolizumab (MK-3475) 200 mg i.v. every 3 weeks for up to 35 cycles
Pembrolizumab is a humanized antibody used in cancer immunotherapy.
Other Name: Keytruda
Patients with osteosarcoma, who are not eligible for surgery of curative intent and have completed at least one line of systemic therapy, will be considered for treatment with pembrolizumab. Patients who are considered medically unfit for chemotherapy and where no other treatment options are believed to be of major benefit may also be considered. Patients will receive pembrolizumab for up to 35 cycles.
Patients, who have received 35 cycles of pembrolizumab or discontinued study treatment of another reason than progression, will in the follow-up period be assessed for safety and treatment-related toxicity (for up to 90 days), progression and survival.
Patients who have achieved a clinically meaningful response after 35 cycles of pembrolizumab, defined as complete response (CR), partial response (PR), and stable disease (SD) assessed by the Investigator by using RECIST, v1.1, and have not experienced any clinically significant toxicity of study treatment, may be considered for reintroduction of pembrolizumab, if progression is detected > 8 weeks after cycle 35.
Due to the low incidence of osteosarcoma, the inclusion rate is expected to be low, thus a Simon's two-stage design is suggested. Evaluation of efficacy and safety in stage one will be performed after the first 12 patients have been treated for 18 weeks:
- In case of ≤2 responders; the trial ends.
- If ≥3 responders, the trial will continue into stage II to a total number of 25 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03013127
|Contact: Kjetil Boye, MD||22934000 ext +firstname.lastname@example.org|
|Istituto Ortopedico Rizzoli||Not yet recruiting|
|Contact: Emanuela Palmerini, MD email@example.com|
|Oslo University Hospital||Recruiting|
|Contact: Kjetil Boye, MD firstname.lastname@example.org|
|Principal Investigator:||Kjetil Boye, MD||Oslo University Hospital|