Trial · NCT03123276
Pembrolizumab and Gemcitabine Chemotherapy in Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma
NCT03123276, Phase 1, Phase 2, Completed, Royal Marsden NHS Foundation Trust; results first posted 2026-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab and Gemcitabine Chemotherapy in Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma. Trials, record NCT03123276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03123276
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab and Gemcitabine Chemotherapy in Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma
- NCT number
- NCT03123276
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Conditions
- Sarcoma
- Interventions
- Pembrolizumab, Gemcitabine
- First posted
- 2017-04-21
- Last updated
- 2026-02-13
- Results first posted
- 2026-02-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Dose Limiting Toxicities. | Treatment start date until completion of 1 full cycle of treatment (21 days) | Part A dose escalation part patients were treated cohorts and assessed for safety until the maximum tolerated dose of gemcitabine that can be safely combined with pembrolizumab in the absence of dose limiting toxicities (DLT). Outcome measure here is the proportion of patients with DLT for each dose level. Protocol definition of DLT: (1) Neutropenia \<0.5 x 109/L for \>5 days. This must be confirmed with repeat blood tests at the Royal Marsden Hospital within 6 days of the diagnosis of neutropenia. (2) Febrile neutropaenia as per definition by ESMO (\>38.3°C or two consecutive readings of \>38.0°C for 2 hours and an absolute neutrophil count (ANC) of \<0.5 x 109/L or expected to fall below \<0.5 x 109/L). (3) Thrombocytopenia \<25 x 109/L. (4) Any non-haematological CTCAE Grade 3 or 4 toxicity that is, in the opinion of the investigator, clinically significant. All the above must be in the investigator's opinion, likely to be causally linked with the administration of Gemcitabine. |
| Secondary | Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Treatment initiation until 9 weeks of starting treatment | Objective response rate presented as number and proportion of patients with a response of CR or PR at 9 weeks of starting treatment according to the RECIST criteria. Similarly, for disease control rate proportion of patients with a response of CR or PR or SD at 9 weeks. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Dose Limiting Toxicities. | Treatment start date until completion of 1 full cycle of treatment (21 days) | Intention to treat - Cohort of patients recruited in the individual dose levels and received at least 1 treatment dose during the Part A dose escalation phase of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Treatment initiation until 9 weeks of starting treatment | Intention to treat analysis population: all patients consented and registered into the study and have had treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Dose Limiting Toxicities. | Cohort 1 - 800mg/m2 Gemcitabine | 0 | Participants | ||
| Number of Patients With Dose Limiting Toxicities. | Cohort 2 - 1000mg/m2 of Gemcitabine | 1 | Participants | ||
| Number of Patients With Dose Limiting Toxicities. | Cohort 3 - 1200mg/m2 Gemcitabine | 0 | Participants | ||
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Cohort 1: 800mg/m2 Gemcitabine | Objective response rate (ORR) | 0 | Participants | |
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Cohort 2: 1000mg/m2 Gemcitabine | Objective response rate (ORR) | 1 | Participants | |
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Cohort 3: 1200mg/m2 Gemcitabine | Objective response rate (ORR) | 2 | Participants | |
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine | Objective response rate (ORR) | 2 | Participants | |
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Cohort 1: 800mg/m2 Gemcitabine | Disease control rate (DCR) | 3 | Participants | |
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Cohort 2: 1000mg/m2 Gemcitabine | Disease control rate (DCR) | 6 | Participants | |
| Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control | Cohort 3: 1200mg/m2 Gemcitabine | Disease control rate (DCR) | 1 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: 800mg/m2 Cohort 1: 800mg/m2 | 3 | |
| Overall Study | STARTED | Cohort 2: 1000mg/m2 | 7 | |
| Overall Study | STARTED | Cohort 3: 1200mg/m2 | 3 | |
| Overall Study | STARTED | Part B Dose Expansion Cohort - 1200mg/m2 | 12 | |
| Overall Study | COMPLETED | Cohort 1: 800mg/m2 Cohort 1: 800mg/m2 | 3 | |
| Overall Study | COMPLETED | Cohort 2: 1000mg/m2 | 7 | |
| Overall Study | COMPLETED | Cohort 3: 1200mg/m2 | 3 | |
| Overall Study | COMPLETED | Part B Dose Expansion Cohort - 1200mg/m2 | 12 | |
| Overall Study | NOT COMPLETED | Cohort 1: 800mg/m2 Cohort 1: 800mg/m2 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2: 1000mg/m2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events536
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 - 800mg/m2 Gemcitabine | 1 | 3 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 - 1000mg/m2 Gemcitabine | 4 | 7 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3 - 1200mg/m2 Gemcitabine | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine | 2 | 12 | 7 |
| other | Hyperthyroidism | Endocrine disorders | Cohort 1 - 800mg/m2 Gemcitabine | 1 | 3 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Cohort 2 - 1000mg/m2 Gemcitabine | 3 | 7 | 4 |
| other | Hyperthyroidism | Endocrine disorders | Cohort 3 - 1200mg/m2 Gemcitabine | 0 | 3 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine | 0 | 12 | 0 |
| other | Hypothyroidism | Endocrine disorders | Cohort 1 - 800mg/m2 Gemcitabine | 3 | 3 | 5 |
| other | Hypothyroidism | Endocrine disorders | Cohort 2 - 1000mg/m2 Gemcitabine | 4 | 7 | 5 |
1 to 10 of 536Source ClinicalTrials.gov
See all 536 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - 800mg/m2 Gemcitabine | 3 | 3 |
| Total, all-cause mortality | Cohort 2 - 1000mg/m2 Gemcitabine | 5 | 7 |
| Total, all-cause mortality | Cohort 3 - 1200mg/m2 Gemcitabine | 2 | 3 |
| Total, all-cause mortality | Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine | 5 | 12 |
| Total, other adverse events | Cohort 1 - 800mg/m2 Gemcitabine | 3 | 3 |
| Total, other adverse events | Cohort 2 - 1000mg/m2 Gemcitabine | 7 | 7 |
| Total, other adverse events | Cohort 3 - 1200mg/m2 Gemcitabine | 3 | 3 |
| Total, other adverse events | Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine | 12 | 12 |
| Total, serious adverse events | Cohort 1 - 800mg/m2 Gemcitabine | 2 | 3 |
| Total, serious adverse events | Cohort 2 - 1000mg/m2 Gemcitabine | 2 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03123276
GET https://conductscience.org/api/trials/v1/NCT03123276/events?page=2