Clinical Trials Logo

Clinical Trial Summary

The three tumour streams that will be studied in this protocol are: (i) upper GI malignancies (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and (iii) rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours). The role of immunotherapy is being defined in more common cancer types, however because of their rarity, the efficacy of immunotherapy for these cancers is poorly defined. This protocol provides an important opportunity to establish whether the combination of nivolumab & ipilimumab has efficacy in these cancers.


Clinical Trial Description

This is a phase 2 clinical trial of nivolumab combined with ipilimumab in subjects with rare cancers. This study will allow an evaluation of the clinical benefit, as measured by progression free survival (PFS) and overall survival (OS), provided by nivolumab combined with ipilimumab. If the safety profile is acceptable and clinically efficacy is seen, this study would support the use of nivolumab combined with ipilimumab in subjects with these cancers. Study Rationale Clinically advanced rare cancers pose a significant clinical challenge because evidence based treatments are seldom available for patients suffering from these malignancies. Despite little evidence that shows clinical benefit, these patients are often treated with chemotherapeutic agents that are used in patients with more common malignancies that arise from the same anatomical site. Furthermore, because of small numbers, they are often excluded from clinical trials with newer agents. The rare care project has defined a rare malignancy as a cancer with an incidence of less than 6/100000/year. It is estimated that 42,000 people are diagnosed with a form of rare or less common cancer in Australia every year (www.canceraustralia.gov.au). The cancer specific survival of patients diagnosed with a rare malignancy is significantly lower than with common cancers highlighting the need to improve management and treatment of these patients. Given the recent success of cancer immunotherapy with checkpoint regulators such as ipilimumab and nivolumab in a whole range of different cancer types, it can be postulated that these agents could be beneficial in rare cancers and improve the overall outlook of patients with these conditions. It is proposed here that patient cohorts which fall within three distinct tumour streams will be examined, with all patients receiving ipilimumab and nivolumab as combination immunotherapy. The three tumour streams are defined as: upper GI malignancies (comprising intra-hepatic/ extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal cancers).); neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid tumours) and rare gynaecological tumours (including but will not be limited to: vaginal or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer, mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa cell tumours). Although overall response rates for individual tumour types will not be established due to sample size (target 20 patients per tumour stream, n=60 total), descriptive information of individual patient responses will guide immune-directed therapies to responsive rare tumour types and may be broadened to tumour streams. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02923934
Study type Interventional
Source Olivia Newton-John Cancer Research Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 22, 2017
Completion date December 2023

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Not yet recruiting NCT05044312 - Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis N/A
Active, not recruiting NCT05053191 - Advancing Nursing Practices in Hospital Oncology Care N/A
Completed NCT03611309 - Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT06398314 - Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors N/A
Withdrawn NCT04030624 - Remote Electronic Patient Monitoring in Gastrointestinal Cancer N/A
Completed NCT02140593 - The Laparotomy Study Phase 4
Completed NCT02222259 - A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients N/A
Active, not recruiting NCT00716209 - Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers N/A
Recruiting NCT01484444 - Biomarker Analysis of Gastrointestinal Cancer N/A
Completed NCT02130427 - A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy N/A
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00094965 - Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function Phase 2
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Recruiting NCT05429866 - Immunological Variables Associated to ICI Toxicity in Cancer Patients Phase 2
Recruiting NCT05226221 - Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
Recruiting NCT03286348 - Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer N/A