Trial reportCancer immunology, immunotherapy : CII2021
Pembrolizumab in advanced osteosarcoma: results of a single-arm, open-label, phase 2 trial.
Trial report in Cancer immunology, immunotherapy : CII, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 83 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PROMO: A Phase II Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery
MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Resectable Osteosarcoma
Who cites it
83 citing papers in PubMed, 1 synthesis or guideline pooled it, 101 citations in OpenAlex.
- Bibliometric analysis of targeted immunotherapy for osteosarcoma-current knowledge, hotspots and future perspectives.Frontiers in immunology · 2024Pooled it
- MISTOSUS: a phase II trial ofFuture oncology (London, England) · 2026Trial
- Phase 2 trial (NCI-COTC030) of adjuvant inhaled recombinant human IL-15 combined with amputation and adjuvant chemotherapy in dogs with appendicular osteosarcoma.Frontiers in immunology · 2025Trial
- Camrelizumab in combination with doxorubicin, cisplatin, ifosfamide, and methotrexate in neoadjuvant treatment of resectable osteosarcoma: A prospective, single-arm, exploratory phase II trial.Cancer medicine · 2024Trial
- A 'three-axis synergy' immunotherapeutic strategy for malignant bone tumors based on natural bioactives and bioactive materials.Bioactive materials · 2026Review
- Real-world experience with ipilimumab in combination with nivolumab in advanced sarcoma: a retrospective analysis including ultra-rare sarcomas.The oncologist · 2026Article
- Paediatric therapeutic development workshop on osteosarcoma.British journal of cancer · 2026Review
- Article
- IL-18 derived from microwave-ablated osteosarcoma facilitates antitumor response.Journal for immunotherapy of cancer · 2026Article
- Understanding and Overcoming Osteosarcoma Heterogeneity.Biomolecules · 2026Review
- Engineering Osteoimmune Responses with Functionalized Orthopedic Implants for Post-Operative Osteosarcoma Treatment.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- A conceptual blueprint for "turning cold to hot" in Osteosarcoma: from TME stratification hypotheses to adaptive therapeutic prospects.Cell communication and signaling : CCS · 2026Review
- Epigenetic remodeling in sarcoma promotes T-cell infiltration via modulation of the Hippo pathway.Journal for immunotherapy of cancer · 2026Article
- Oncostatin-M ligand-based CAR-T therapy displays robust anti-tumor activity against osteosarcoma.BMC medicine · 2026Article
- <p>Tumor microenvironment in bone sarcomas: Implications for immunotherapy and emerging therapeutic vulnerabilities (Review)</p>.Oncology reports · 2026Review
- From Bench to Bedside: Advancements in Precision Oncology and Drug Discovery for Osteosarcoma.Cancers · 2026Review
- Antitumor Effects of PD-1 Blockade Combined with Mild Hyperthermia in a Murine Osteosarcoma Model.Biomedicines · 2026Article
- Dynamic changes in peripheral blood lymphocyte subsets predict the efficacy and prognosis of immune checkpoint inhibitors in metastatic osteosarcoma.Frontiers in immunology · 2026Article
- Navigating the immunosuppressive abyss: current hurdles and innovative breakthroughs in neoadjuvant immunotherapy for osteosarcoma.Frontiers in immunology · 2026Review
- Delayed Aggressive Local Recurrence of Chondroblastic Osteosarcoma 3 Years After an Excellent Pathological Response: A Case Report.Clinical case reports · 2026Article
23 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma. MATERIAL AND
methodsThe study was a single-arm, open-label, phase 2 trial in patients with unresectable, relapsed osteosarcoma. The primary endpoint was clinical benefit rate (CBR) at 18 weeks of treatment, defined as complete response, partial response, or stable disease using RECIST v1.1. The trial had a Simon´s two-stage design, and ≥ 3 of 12 patients with clinical benefit in stage 1 were required to proceed to stage 2. The trial is registered with ClinicalTrials.gov, number NCT03013127. NanoString analysis was performed to explore tumor gene expression signatures and pathways.
resultsTwelve patients were enrolled and received study treatment. No patients had clinical benefit at 18 weeks of treatment, and patient enrollment was stopped after completion of stage 1. Estimated median progression-free survival was 1.7 months (95% CI 1.2-2.2). At time of data cut-off, 11 patients were deceased due to osteosarcoma. Median overall survival was 6.6 months (95% CI 3.8-9.3). No treatment-related deaths or drug-related grade 3 or 4 adverse events were observed. PD-L1 expression was positive in one of 11 evaluable tumor samples, and the positive sample was from a patient with a mixed treatment response.
conclusionIn this phase 2 study in advanced osteosarcoma, pembrolizumab was well-tolerated but did not show clinically significant antitumor activity. Future trials with immunomodulatory agents in osteosarcoma should explore combination strategies in patients selected based on molecular profiles associated with response.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.