Table 2.
Trial treatment schedule
| Drug | Dose/Potency | Frequency | Time of oral intake | Route of Administration | Treatment Period | Remarks | |||
|---|---|---|---|---|---|---|---|---|---|
| 8 h | 12 h | 18 h | 20 h | ||||||
| Pembrolizumab (Keytruda) | 200 mg | Q3W | IV infusion | Day 1 of each 3-week cycle |
May be discontinued upon unacceptable toxicity Administration should be withheld for drug-related non-hematologic toxicity ≥ grade 2 (excluding fatigue) Use corticosteroids for irAE |
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| Radiation | 8 Gy | 3 fractions 48 h apart | Day 1, 3 and 5 of Pembrolizumab cycle 1 | See Additional file 1 | |||||
| Vitamin D3 (D-Cure) | 2000 IU (50 μg) a | Daily | X | Oral | Daily from day −14 |
Intake of other vitamin D preparations should be stopped Blood should be monitored for calcium and phosphate Caution in patients receiving digitalis preparations |
|||
| Lansoprazole (Lansoprazole Teva) |
180 mg (uneven weeks); 30 mg (even weeks) b |
Daily | X | X c | Oral | Daily from day −12 |
Needs to be taken at least 30 min before a meal Patients taking any kind of proton pump inhibitors should switch to Lansoprazole Teva throughout the study period Must be taken 2 h apart from all other orally administered drugs |
||
| Aspirin (Sedergine) | 325 mg d | Daily | X | Oral | Daily from day −11 | Patients receiving any other anti-coagulant therapy should switch to Sedergine throughout the study | |||
| Cyclophosphamide (Endoxan) | 50 mg e | Daily | X | Oral | Daily from day −10 |
Monitor leukocyte levels regularly during treatment Do not administer to patients with leukocyte levels < 2500/μl and/or thrombocyte levels of < 50,000/μl Consumption of grapefruit and its derivatives is counter-advised |
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| Curcumin (CurcuPhyt) (Food supplement, NIMP) | 2 g f | Daily | X | X | Oral | Daily from day −13 |
Patients are suggested to not take H2 Beta blockers (beta-adrenoreceptor antagonists) Proton pump inhibitors should be consumed 2 h apart Patients should not consume other turmeric containing food |
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a30 drops should be resolved in fat-containing drink, e.g. milk
b Capsules should be swallowed entirely with fluid
c uneven weeks only
d Effervescent tablets should be dissolved in water
e Tablets should be taken with a large amount of fluid.
f Capsules should be taken with a meal and not be chewed on