Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles

Stereotactic Ablative Body Radiosurgery (SABR)

Pembrolizumab at a dose of 200mg IV, 3-weekly will be delivered for a duration of 6 months, commencing 5 days (+/- 3 days) from the last dose of SABR.

Shankar Siva, Prof

This investigator driven study will examine the safety, efficacy and biological effects of combining pembrolizumab (MK-3475) an antibody targeted against anti-programmed cell death 1 (PD-1), with stereotactic ablative body radiotherapy (SABR) for oligometastatic renal cell carcinoma (RCC). The investigators hypothesise that the safety profile of this combination will be clinically acceptable.

Dual institutional, single arm, unblinded, phase I/II study.

Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours

Number of Participants with Grade 3 Treatment Related Adverse Events as determined using CTCAE version 4.03 criteria. This standard criteria can be found through National Cancer Institute (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm). Grade 3 treatment-related events are high grade toxicities.

Freedom from local progression (FFLP) was defined as the absence of progressive disease by the Response Evaluation Criteria in Solid Tumors criteria

Percentage of Participants with Distant Progression Free Survival (DPFS)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The number of patients who reported a pain score \>0 at least once after treatment. Numerical Pain Rating Score, 0-10 scale with 0 representing no pain, to 10 representing the worst possible pain.

Peter MacCallum Cancer Centre, Australia

SABR treatment (18Gy-20Gy/1#) followed by 200mg pembrolizumab IV once every 3 weeks for a total of 8 cycles

Stereotactic Ablative Body Radiosurgery (SABR): 18-20Gy in 1 fraction

Pembrolizumab: Pembrolizumab at a dose of 200mg IV, 3-weekly will be delivered for a duration of 6 months, commencing 5 days (+/- 3 days) from the last dose of SABR.

SABR + Pembrolizumab

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Office of Cancer Research

Toxicities Measured Using CTCAE Version 4.03

Overall Survival

Freedom From Local Progression (FFLP)

Distant Progression Free Survival (DPFS)

Overall Response Assessed Using RECIST 1.1

Pain Assessed Using the Numerical Pain Rating Scale

Overall Study

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Breast Neoplasms

Bone Neoplasms

Breast Diseases

Skin Diseases

Bone Diseases

SABR treatment (20Gy in 1 fraction) to at least one metastases (to a maximum of 5 metastases) followed by 8 cycles of 3 weekly treatment with MK-3475 (200mg IV per dose).

Stereotactic Ablative Body Radiosurgery (SABR) - a single 20Gy in 1 fraction.

MK-3475 (200mg IV) on day 1 every 3 weeks for a total of 8 cycles.

MK-3475

Sherene Loi, A/Prof.

Steven David, Dr

This is a prospective, observational pilot study that will describe the safety profile and biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment (20Gy/1#) and a PD-1 antibody, MK-3475.

15 patients with oligometastatic breast cancer with at least one lesion considered safe for SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition to 6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles).

This investigator driven pilot study will examine the safety and biological effects of combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell death 1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We hypothesise that the safety profile of this combination, will be clinically acceptable and well tolerated for patients, and that we will observe evidence of systemic immune activation.

Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475

A Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475.

Difference in levels of PD-L1 expression in primary tumor and metastatic lesions using immunohistochemistry (if possible).

Difference in levels of TILs using a previously defined method between primary tumour and metastatic lesions (if possible).

Safety profile will be evaluated using CTCAE v4.0 in all patients who have received at least one SABR treatment and one dose of MK-3475. Acute AE are defined as AE's occurring from the time from 1st SABR treatment to 30 days post end of MK-3475 treatment and long term AE are defined as AE's occurring after 30 days post end of MK-3475 treatment.

Blood samples will be collected (50ml) at baseline (prior to first SABR), prior to the first dose of MK-3475, prior to cycle 2 of MK-3475, at disease progression (if this occurs) and then every 3 months up to two years post end of SABR treatment. These will be analysed for the following (this is a non-exhaustive list):

i. Absolute lymphocyte counts using a blood analyser.

ii. The presence of CD8+ T cells by flow cytometric analysis.

iii. Change in frequency of tumor reactive T cells. These may include markers for HLA-DR, CD4+, CD8+ T cells, PD-1, TIM-3 signifying antigen presentation and experience.

Pain levels will be evaluated pre and post-treatment using the Numerical Rating Pain Scale at the following time points: pre-SABR treatment, at approximately 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and at 24 months after the end of SABR treatment.

LPFS will be assessed at baseline, 1 month post SABR treatment, then at every three months for 24 months or until the date of first local progression, or date of death for patients without local progression.

DPFS will be assessed at baseline, 1 month post SABR treatment, then at every three months for 24 months or until the date of first local progression, or date of death for patients without distant progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours	NCT02855203	Renal Cell Carc...	Stereotactic Ab... Pembrolizumab	18 Years -	Peter MacCallum Cancer Centre, Australia
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475	NCT02303366	Breast Neoplasm... Bone Neoplasms	Stereotactic Ab... MK-3475	18 Years -	Peter MacCallum Cancer Centre, Australia
Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours	NCT02855203	Renal Cell Carc...	Stereotactic Ab... Pembrolizumab	18 Years -	Peter MacCallum Cancer Centre, Australia

Spots Global Cancer Trial Database for stereotactic ablative body radiosurgery (sabr)