Dostarlimab Clinical Trials

What Is Dostarlimab?

Dostarlimab is an FDA-approved medication for certain types of cancer. It is a type of immunotherapy known as a PD-1 inhibitor, specifically an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody. Dostarlimab works by binding to programmed cell death protein 1 (PD-1), which helps the body's own immune system recognize and fight cancer cells.

This drug is currently being studied in 87 clinical trials, with 29 trials actively recruiting participants and 9 trials already completed. These studies have enrolled a total of 18,996 participants. The first trial involving dostarlimab began on January 5, 2010, and the latest planned trial is set to conclude by February 12, 2026. Major sponsors of these trials include GlaxoSmithKline and Tesaro, Inc.

Uses and Conditions Under Study

Dostarlimab is being investigated for its potential to treat various types of cancer, leveraging its ability to enhance the immune system's response against tumor cells. Clinical trials are exploring its use both as a standalone treatment and in combination with other therapies.

• General Cancers: Dostarlimab is being studied broadly for neoplasms, which are abnormal growths of tissue. There are 13 trials investigating its effects across different types of cancer, aiming to understand its general effectiveness in stimulating the immune system to fight these diseases.
• Gynecological Cancers: A significant focus of research is on cancers affecting the female reproductive system. This includes endometrial cancer, with 7 trials, and ovarian neoplasms and ovarian cancer, with a combined 5 trials. Dostarlimab is being explored as a treatment option, especially for women who may not be suitable for traditional surgery.
• Lung Cancer: For non-small cell lung cancer (NSCLC), which accounts for a large percentage of all lung cancers and is often diagnosed at advanced stages, dostarlimab is being evaluated in 5 trials. As a PD-1 inhibitor, it aims to help the immune system target and fight these aggressive lung tumors.
• Other Cancers: Dostarlimab is also under investigation for several other cancer types. This includes breast cancer (3 trials), head and neck cancer (3 trials), gastric adenocarcinoma (3 trials), rectal neoplasms (2 trials), and neuroendocrine carcinoma (2 trials). These studies aim to determine if dostarlimab can offer therapeutic benefits in these diverse cancer settings.

Dosing

Dostarlimab is administered as an injectable solution, typically given intravenously. The specific dosage and schedule can vary depending on the condition being treated and whether it is used alone or in combination with other medications.

In clinical trials, common dosing regimens for adults have included 500 mg every 3 weeks (Q3W) during phases of chemoimmunotherapy. Another studied dose is 1000 mg every 6 weeks (Q6W), which has been identified as an appropriate dose across various indications and tumor types in the dostarlimab development program.

For example, in some neoadjuvant settings (treatment given before surgery), participants received 500 mg every 3 weeks for 4 cycles. Following surgery, adjuvant therapy (additional treatment) including dostarlimab was administered. The drug has also been studied in various combination therapies, such as with carboplatin-paclitaxel, niraparib, and other investigational agents.

Side Effects

• Discontinuation of the study due to adverse events occurred in 52.1% of patients receiving the Dostarlimab-containing regimen, compared to 54.6% in the placebo-containing regimen.
• Treatment-emergent positive anti-drug antibodies against Dostarlimab were observed in 7.98% of patients in the Dostarlimab-containing regimen.

Currently Recruiting Trials

Dostarlimab is currently being investigated in numerous clinical trials to explore its potential in treating various cancers, often in combination with other therapies. These studies aim to understand its effectiveness, safety, and how it can improve patient outcomes.

One study, NCT07408063, known as the BeeHive study, is a Phase 2 trial enrolling 30 participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). It evaluates dostarlimab in combination with GSK5764227. Another Phase 1/Phase 2 study, NCT06405230, sponsored by GlaxoSmithKline, is recruiting 40 participants with non-small cell lung cancer to assess biomarker tools for predicting treatment response to dostarlimab or pembrolizumab, potentially with chemotherapy.

For small cell neuroendocrine cervical carcinoma, NCT07336147 is a Phase 2 trial with an enrollment target of 45 participants, investigating dostarlimab alongside chemoradiation with etoposide and cisplatin. In endometrial cancer, a Phase 2 study (NCT07108270) is enrolling 30 Chinese participants to evaluate dostarlimab with carboplatin-paclitaxel, followed by dostarlimab monotherapy.

Several trials focus on colorectal cancers. NCT07269249 is an observational study of 50 participants with dMMR/MSI-H locally advanced rectal cancer, examining real-world efficacy and safety. A Phase 2 study (NCT06830239) is testing neoadjuvant dostarlimab monotherapy in 10 participants with resectable colon cancer. Additionally, NCT06567782, a Phase 2 trial, compares dostarlimab plus CAPEOX chemotherapy against CAPEOX alone in 120 participants with specific colon cancer types. A larger Phase 3 study, NCT05855200, aims to enroll 892 participants with dMMR/MSI-H resectable colon cancer to compare perioperative dostarlimab with standard of care.

Other studies include NCT06796907, a Phase 1/Phase 2 trial with 305 participants for advanced solid tumors, combining dostarlimab with mocertatug rezetecan for endometrial cancer. Pancreatic cancer is the focus of NCT06757244, a Phase 2 study enrolling 35 participants to evaluate dostarlimab with mFOLFIRINOX and vitamin D3. A Phase 3 study (NCT06762405) is recruiting 68 participants with dMMR/MSI-H locally advanced rectal cancer to assess neoadjuvant dostarlimab with short course radiotherapy.

Where to Participate

Clinical trials for Dostarlimab are being conducted across a wide geographic area, with 63 sites in 99 cities across 37 states. This broad reach helps ensure diverse participation in these important studies.

The top locations with the most recruiting sites include:

• New York, New York (9 sites)
• Sioux Falls, South Dakota (5)
• Dallas, Texas (5)
• Houston, Texas (5)
• Cleveland, Ohio (4)
• New Haven, Connecticut (4)
• Chicago, Illinois (4)
• St Louis, Missouri (3)
• Omaha, Nebraska (3)
• Washington D.C., District of Columbia (3)

To be eligible for most of these trials, participants must generally be between 18 and 75 years of age. These studies are designed for individuals with specific medical conditions, and healthy volunteers or children are not eligible to participate.

Development Timeline

The development journey for Dostarlimab began on January 5, 2010, with the initiation of its first clinical trial. Since then, the drug has been investigated in a total of 87 trials, enrolling nearly 19,000 participants (18,996).

Initially, early studies explored Dostarlimab for conditions such as IBS-C and hyperphosphatemia. However, the development pipeline quickly expanded, shifting focus to a wide range of oncology indications. This strategic expansion led to investigations in various cancers, including non-small cell lung cancer, ovarian neoplasms, breast cancer, head and neck cancer, and gastric adenocarcinoma.

Over time, the scope broadened further to include locally advanced rectal cancer, neuroendocrine carcinoma, endometrial neoplasms, and many other solid tumors. This progression reflects a concerted effort to identify where Dostarlimab can offer the most therapeutic benefit. The majority of these studies have advanced through Phase 1 and Phase 1/Phase 2, with 49 trials reaching Phase 2, and 9 trials progressing to Phase 3, indicating significant progress in its clinical evaluation.

GlaxoSmithKline has been a primary driver in Dostarlimab's development, sponsoring 26 trials. Other key institutions like M.D. Anderson Cancer Center, University Health Network, and Memorial Sloan Kettering Cancer Center have also played significant roles in advancing its research. The latest trial is projected to conclude on February 12, 2026, underscoring ongoing commitment to exploring Dostarlimab's full potential.