CDSCO dostarlimab Phase IV trial research has taken another step forward in India after the Subject Expert Committee (SEC) on Oncology recommended permission for a Phase IV clinical study of dostarlimab in adults with primary advanced or recurrent endometrial cancer.
The recommendation was made during the SEC (Oncology) meeting held on August 5, 2026, at CDSCO Headquarters, New Delhi. GSK Pharma India presented the proposed study, identified as Study 309169, which is designed to evaluate the safety of dostarlimab in patients in India.
The recommendation is subject to the applicable regulatory requirements and permissions.
Quick Summary
CDSCO’s SEC (Oncology) has recommended a Phase IV clinical trial of dostarlimab in adults with primary advanced or recurrent endometrial cancer in India. The GSK-sponsored Study 309169 is an open-label, single-arm, multicenter study focused on safety. The recommendation includes conditions concerning investigators, trial sites and post-trial access.
CDSCO Dostarlimab Phase IV Trial: Key Details
| Particular | Details |
|---|---|
| Regulatory authority | CDSCO |
| Committee | SEC (Oncology) |
| Meeting date | August 5, 2026 |
| Sponsor | GSK Pharma India |
| Study ID | 309169 |
| Trial phase | Phase IV |
| Study design | Open-label, single-arm, interventional, multicenter |
| Drug | Dostarlimab |
| Strength | 500 mg/10 mL (50 mg/mL) |
| Target population | Adults with primary advanced or recurrent endometrial cancer |
| Estimated enrollment | 100 participants |
| Study period | August 2026 to August 2030 |
| Current registry status | Not yet recruiting |
The GSK clinical trial registry identifies Study 309169 as a Phase IV, single-group interventional study with an estimated enrollment of 100 participants. The study evaluates dostarlimab in combination with carboplatin and paclitaxel followed by dostarlimab monotherapy.
What Did CDSCO’s SEC Recommend?
The SEC recommended permission to conduct the proposed Phase IV clinical trial according to the protocol presented by GSK Pharma India.
The study is titled:
“Phase 4, open label, single-arm, interventional, multicenter study to evaluate the safety of dostarlimab in adult patients in India with primary advanced or recurrent endometrial cancer.”
The study is identified as GSK Study 309169.
According to the GSK study registry, the trial is designed to evaluate the safety of dostarlimab when used with carboplatin and paclitaxel, followed by dostarlimab monotherapy, as first-line treatment in advanced or recurrent endometrial cancer.
Important Conditions Recommended by the SEC
The recommendation includes specific conditions for conducting the study:
- All Principal Investigators (PIs) should be Medical Oncologists.
- Day-care facilities should not be used as clinical trial sites.
- Participating trial sites should be geographically distributed.
- Participating subjects should receive post-trial access to the study drug until disease progression, as specified by the recommendation.
These conditions are important for the conduct and oversight of the proposed Phase IV study.
What Is Dostarlimab?
Dostarlimab is a monoclonal antibody that targets programmed cell death protein 1 (PD-1), an immune checkpoint receptor.
By blocking PD-1 signalling, dostarlimab can help enhance immune-system activity against cancer cells.
In India, JEMPERLI (dostarlimab) is supplied as a concentrate for solution for infusion containing 500 mg in 10 mL, equivalent to 50 mg/mL.
Dostarlimab Mechanism of Action
The basic mechanism can be summarized as:
Dostarlimab → PD-1 blockade → Reduced inhibitory signalling → Enhanced T-cell-mediated antitumour response
Dostarlimab therefore belongs to the class of immune checkpoint inhibitors.
Dostarlimab and Endometrial Cancer
Endometrial cancer develops in the lining of the uterus and is one of the major gynecological cancers.
GSK’s current Indian prescribing information lists JEMPERLI for use with carboplatin and paclitaxel as first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. It also lists monotherapy for certain adults with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior platinum-containing treatment.
GSK has also reported that JEMPERLI received first-line approval in India for primary advanced and recurrent endometrial cancer.
What Is Study 309169?
Study 309169 is the proposed Phase IV study being conducted in India.
Study Design
The trial is:
- Phase IV
- Interventional
- Open-label
- Single-group
- Multicenter
- Designed primarily to evaluate safety
The GSK registry lists an estimated 100 participants and a study period from August 2026 to August 2030. The current study status is “Not yet recruiting.”
Who May Be Eligible for the Study?
The GSK trial registry lists adults aged 18 years or older with histologically or cytologically confirmed advanced or recurrent endometrial cancer.
The listed criteria include patients with:
- Primary Stage III or Stage IV disease, or
- First recurrent endometrial cancer with limited potential for cure by surgery or radiation alone or in combination, based on investigator assessment.
- ECOG performance status of 0 or 1.
- Eligibility for dostarlimab according to the approved prescribing information and investigator’s clinical judgement.
- Ability to provide informed consent.
The registry also lists additional inclusion and exclusion criteria that must be assessed by investigators.
Important Eligibility Note
This is a clinical trial eligibility profile, not a general treatment eligibility checklist. Final eligibility will depend on the complete study protocol and assessment by the trial investigators.
What Is the Main Objective of the Trial?
The main focus of Study 309169 is safety evaluation.
The GSK registry includes safety assessments such as treatment-emergent adverse events, serious adverse events, treatment-related adverse events and immune-mediated adverse events. It also includes monitoring of vital signs and ECG parameters.
Key Safety Outcomes
| Safety Parameter | Assessment |
|---|---|
| Treatment-emergent adverse events | Yes |
| Serious adverse events | Yes |
| Treatment-related adverse events | Yes |
| Immune-mediated adverse events | Yes |
| Vital signs | Yes |
| ECG parameters | Yes |
| Fatal adverse events | Monitored |
| Treatment discontinuation due to adverse events | Monitored |
What Treatment Will Be Studied?
The study registry describes treatment with:
Dostarlimab + Carboplatin + Paclitaxel
followed by:
Dostarlimab monotherapy
This treatment sequence is being evaluated as first-line treatment in the study population.
Why Is a Phase IV Clinical Trial Important?
Clinical trials are conducted in different phases to generate evidence about a medicine’s safety and effectiveness.
A Phase IV clinical trial is generally conducted after regulatory approval and can provide additional information from broader clinical use.
Phase IV studies can help evaluate:
- Post-approval safety
- Adverse drug reactions
- Long-term safety
- Safety in specific populations
- Treatment patterns
- Additional clinical outcomes
- Rare or less common safety signals
For pharmacy students, Phase IV trials are closely connected with pharmacovigilance and post-marketing surveillance.
Is the Dostarlimab Trial Approved or Only Recommended?
This distinction is important.
The information discussed here concerns a recommendation by the CDSCO Subject Expert Committee.
A committee recommendation should not automatically be described as final regulatory authorization. The proposed study remains subject to applicable CDSCO requirements and permissions before it can proceed.
The CDSCO maintains an official SEC recommendations portal where committee recommendations are published.
Is the Trial Currently Recruiting?
No.
The GSK clinical trial registry currently lists Study 309169 as “Not yet recruiting.”
Therefore, readers should not interpret the SEC recommendation as confirmation that patient recruitment has already started.
What Does This Development Mean for Endometrial Cancer Research?
The proposed trial will generate additional safety information on dostarlimab in the Indian population.
This is particularly relevant because treatment response and safety can vary across patient populations, and post-approval studies can provide additional evidence from routine clinical settings.
The study’s multicenter design and geographically distributed trial sites, as recommended by the SEC, may also help broaden the Indian clinical evidence base.
Why Should Pharmacy Candidates Know About This Update?
This development is highly relevant for B.Pharm, D.Pharm, M.Pharm, Pharm.D and pharmacy competitive-exam aspirants.
It connects several important pharmacy concepts:
For Pharmacology
- Monoclonal antibodies
- Immune checkpoint inhibitors
- PD-1 pathway
- Cancer immunotherapy
- Antineoplastic drugs
For Clinical Research
- Phase IV clinical trials
- Clinical trial protocols
- Study design
- Inclusion and exclusion criteria
- Safety endpoints
For Regulatory Affairs
- CDSCO
- Subject Expert Committee
- Clinical trial permission
- Post-marketing studies
- Regulatory review
For Pharmacovigilance
- Adverse drug reactions
- Serious adverse events
- Immune-mediated adverse events
- Post-approval safety monitoring
This makes the update useful for students preparing for GPAT, NIPER JEE, Drug Inspector and Pharmacist examinations.
Earlier CDSCO Review of Dostarlimab
Dostarlimab has been evaluated by the CDSCO SEC previously.
In December 2023, the SEC recommended a Phase IV clinical study of dostarlimab in adults with dMMR/MSI-H recurrent or advanced endometrial cancer that had progressed during or after prior platinum-containing treatment. The committee specified a minimum of 30 evaluable patients for that study.
This earlier recommendation is separate from the current Study 309169, which focuses on primary advanced or recurrent endometrial cancer and has an estimated enrollment of 100 participants.
Dostarlimab Phase IV Trial: Key Takeaways
| Question | Answer |
|---|---|
| Which drug? | Dostarlimab |
| Which cancer? | Primary advanced or recurrent endometrial cancer |
| Trial phase? | Phase IV |
| Sponsor? | GSK Pharma India |
| Study ID? | 309169 |
| Estimated enrollment? | 100 |
| Study design? | Open-label, single-arm, multicenter |
| Main focus? | Safety |
| Current status? | Not yet recruiting |
| SEC recommendation? | Permission recommended subject to conditions |
| PI requirement | Medical Oncologists |
| Day-care sites | Not to be used |
| Post-trial access | Recommended until disease progression |
Frequently Asked Questions
1. What did CDSCO recommend for dostarlimab?
CDSCO’s Subject Expert Committee on Oncology recommended permission for a Phase IV clinical trial of dostarlimab in adults with primary advanced or recurrent endometrial cancer in India, subject to specified conditions.
2. What is the dostarlimab Phase IV trial study number?
The proposed trial is identified as GSK Study 309169.
3. Who is sponsoring the dostarlimab clinical trial?
The Phase IV study is sponsored by GSK Pharma India.
4. How many participants are expected in the trial?
The GSK registry lists an estimated enrollment of 100 participants.
5. What is the main purpose of the Phase IV dostarlimab study?
The study is primarily designed to evaluate the safety of dostarlimab in adults with primary advanced or recurrent endometrial cancer in India.
6. Is the dostarlimab Phase IV trial currently recruiting?
No. The GSK registry currently lists Study 309169 as “Not yet recruiting.”
7. What is the mechanism of action of dostarlimab?
Dostarlimab is a PD-1 immune checkpoint inhibitor. It blocks PD-1 signalling, helping restore immune activity against tumour cells.
8. Why is this update important for pharmacy students?
The study covers important topics including monoclonal antibodies, cancer immunotherapy, clinical trial phases, CDSCO regulation, pharmacovigilance and adverse drug-event monitoring.
Conclusion
The CDSCO dostarlimab Phase IV trial recommendation represents another important development in the regulatory and clinical evaluation of immunotherapy for endometrial cancer in India.
The proposed GSK-sponsored Study 309169 is an open-label, single-arm, multicenter Phase IV study designed primarily to evaluate the safety of dostarlimab in adults with primary advanced or recurrent endometrial cancer. The study has an estimated enrollment of 100 participants and is currently listed as not yet recruiting.
The SEC has also recommended specific conditions concerning Medical Oncology investigators, trial-site selection, geographical distribution and post-trial access.
For pharmacy students and professionals, this update is particularly useful for understanding the connection between oncology pharmacology, clinical research, pharmacovigilance and CDSCO regulatory processes.
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