This trial is examining the safety and effectiveness of combination therapy with pembrolizumab (Keytruda) and lenvatinib (Lenvima) for advanced or unresponsive colorectal cancer (CRC) and other solid tumors.
The main outcome to be measured will be the objective response rate (ORR; the percentage of participants who have complete disappearance of tumors) after 2 years.
Some patients with advanced cancer fail to respond or are unsuitable for standard treatments. For these patients, new treatment options are constantly being developed. Pembrolizumab is a targeted therapy used in advanced tumors with abnormal genes. Lenvatinib is another targeted therapy currently used for thyroid, kidney or liver cancer. The safety and effectiveness of the combination of pembrolizumab and lenvatinib in patients with advanced or unresponsive CRC are not known.
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab and lenvatinib in patients with advanced CRC and other solid tumors. The ORR will be the main outcome measured.
Who are they looking for?
180 patients with solid tumors will be recruited. Patients with advanced CRC who are unsuitable for surgery or who have failed previous treatments (at least 2 previous treatments), with adequate organ function who are not pregnant or breastfeeding and agree to use birth control are needed.
Patients will be excluded if they have problems with absorbing nutrients in the diet (malabsorption), major vessel infiltration with tumors, coughing up blood), heart problems or a history of blood clots. Patients with an additional cancer that is progressing, those with wounds that do not heal, patients who had a live vaccine within 30 days of starting the study or a known intolerance to study treatment will also be excluded. Patients with active infections, autoimmune conditions or brain tumors or infections and those with recurrent tumors larger than 6 cm cannot participate.
How will it work
There will be a single group. All patients will receive pembrolizumab 200 mg via intravenous injection (into a vein) on Day 1 of each 21-day cycle plus lenvatinib 20 mg via oral (by mouth) capsule once a day. Pembrolizumab will be administered for up to 35 cycles for 2 years. Lenvatinib will be administered up to at least 2 years or until unacceptable side effects.
Patients will be followed up for up to 36 months and ORR and survival outcomes will be measured.