ICMR funds new clinical trial IPIROC by KOLGOTRG

The Every Woman study – Low and low-middle-income country edition was published in The Lancet on 11 December 2025, with participation from India through the Kolkata Gynaecological Oncology Trials and Translational Research Group (KOLGOTRG). The study reported that access to chemotherapy agents with high costs and limited access to clinical trials are global issues.

At the 8th annual meeting organised by KOLGOTRG, the IPIROC trial (Intermittent PARP Inhibitor Regimen in Ovarian Cancer) was officially launched. The trial was developed by Dr Asima Mukhopadhyay, Consultant Gynaecologist and Clinician Scientist, along with her team. The study is funded by the Indian Council of Medical Research (ICMR) and facilitated by Suraksha Diagnostics Limited. The trial will be open across all states in India and at some sites outside the country. It focuses on identifying PARP inhibitor dosing with reduced side effects and lower cost for selected patients.

The meeting was attended by experts in women’s cancer, including Dr Michael Bookman, Chair of the Gynaecological Cancer Intergroup (GCIG), USA; Dr Amit Oza, Past Chair of GCIG, Canada; Prof Kailash Narayan, Radiation Oncology, Melbourne, Australia; Dr Asima Mukhopadhyay, Director, KOLGOTRG India; Dr Neerja Bhatla, Padma Shri awardee and former Head of Department, AIIMS Delhi; and Prof Val Gebski, Statistician, Sydney, Australia. Faculty from SGPGI, KGMU Lucknow, Tata Memorial Hospital Mumbai, Aster CMI Bengaluru, AIIMS Delhi, NCI Jhajjar and other AIIMS institutions across India were present, along with representatives from BDR Pharma and Cepheid, and members of KOLGOTRG.

KOLGOTRG is the only research group from India and South Asia that is a member of the Global Consortium Gynaecological Cancer Intergroup (GCIG) and is involved in clinical trials and research in women’s cancer.

PARP inhibitors are used in cancer types associated with BRCA gene mutations. These inhibitors block the enzyme poly ADP ribose polymerase, which cancer cells use to repair DNA damage. By preventing DNA repair, cancer cells are destroyed, particularly in tumours with homologous recombination deficiency, which can be identified through HRD assays in ovarian and breast cancer. High cost and side effects often lead to treatment discontinuation. The IPIROC trial is evaluating whether twice-weekly dosing of the PARP inhibitor rucaparib can reduce side effects while maintaining efficacy compared to daily dosing in ovarian cancer patients.

Dr Asima Mukhopadhyay, Director of KOLGOTRG and Regional Ovarian Cancer Centre KOLGOTRG (ROCK), said, “I extend my heartfelt thanks to ICMR for funding this important initiative and request oncologists all across India to inform patients about this study, where free access to a costly anti-cancer drug will be provided through a trial. It is a known fact that there are certain barriers where some physicians or cancer centres do not want to participate in such academic clinical trials, where poor patients can substantially benefit from newer interventions. Many people still don’t know that such an opportunity exists, that by being part of a trial, one can get access to a costly drug.”

She added, “I also want to thank Suraksha Clinic and Diagnostics and Directors Dr Somnath Chatterjee and Ms Ritu Mittal, for immensely facilitating the setting up of the study by providing space for ROCK and provision of laboratory facilities for biobanking and development of next generation biomarker assays like the academic HRD and PARP assay for patient selection, through an unique R&D collaboration with KOLGOTRG.”

Dr Mukhopadhyay further said, “’Academia-industry collaboration is the future’ – citing other examples of KOLGOTRG collaboration with governmental bodies, like the CSIR HCP 40 program in drug development for women’s cancer in India and collaboration with Suraksha Clinic and Diagnostics Ltd and Cepheid global for an international award winning cervical cancer screening project in Tea gardens of Darjeeling district with logistical support from Ministry of Health and family Welfare, Govt of West Bengal and local NGO, Manisha Nandi foundation.”

She also acknowledged the support of BDR Pharmaceuticals for co-funding the first phase of the trial along with the CRUK-DBT seed corn grant, and for support in trial coordination and access to PARP inhibitors for the current ICMR-funded study.

During the meeting, KOLGOTRG recognised industry partners and global mentors for their support and acknowledged the role of government funding bodies, including ICMR, in supporting research activities in India.